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- Page 4

# DeviceEstablishmentPulse: all 1,000 record reports, page 4 of 5

Every DeviceEstablishmentPulse record report, 200 per page, grouped by state. Records 601 to 800: Zimmer India Private Limited (foreign exporter, Gurugram Haryana, IN): 3 new FDA device listings, incl. prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, to Harmony Health Tech Inc (repackager or relabeler, Brooklyn, NY): 3 new FDA device listings, incl. massager, powered inflatable tube. Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

[1](/hub/deviceestablishmentpulse/records) [2](/hub/deviceestablishmentpulse/records/2) [3](/hub/deviceestablishmentpulse/records/3) 4 [5](/hub/deviceestablishmentpulse/records/5)

## Indiana

- [Zimmer India Private Limited (foreign exporter, Gurugram Haryana, IN): 3 new FDA device listings, incl. prosthesis, knee, patello/femorotibial, semi-constrained, uncemented,](/report/deviceestablishmentpulse/zimmer-india-private-limited-gurugram-haryana-in--fdaest-3048147961-2026-05-07)
- [Zimmer, Inc. (contract manufacturer, Warsaw, IN): 28 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/zimmer-inc-warsaw-in--fdaest-1822565-2026-09-29)

## JP

- [3-D Matrix, Ltd. (foreign exporter, Chiyoda-ku Tokyo, JP): 2 new FDA device listings, incl. protective coating, mucoadhesive application, for the rectal mucosa](/report/deviceestablishmentpulse/3-d-matrix-ltd-chiyoda-ku-tokyo-jp--fdaest-3007162658-2026-08-27)
- [Aizu Olympus Co., Ltd. (manufacturer, AIZUWAKAMATSU-SHI Fukushima, JP): 4 new FDA device listings, incl. endoscope, accessories, narrow band spectrum](/report/deviceestablishmentpulse/aizu-olympus-co-ltd-aizuwakamatsu-shi-fukushima-jp--fdaest-9610595-2026-08-31)
- [Aomori Olympus Co., Ltd. Hirosaki Site (repackager or relabeler, Hirosaki-shi Aomori, JP): 4 new FDA device listings, incl. hemostatic metal clip for the gi tract](/report/deviceestablishmentpulse/aomori-olympus-co-ltd-hirosaki-site-hirosaki-shi-aomori-jp--fdaest-3014769442-2026-09-01)
- [AOMORI OLYMPUS CO., LTD. Kuroishi Site (manufacturer, KUROISHI-SHI Aomori, JP): 6 new FDA device listings, incl. forceps, biopsy, electric](/report/deviceestablishmentpulse/aomori-olympus-co-ltd-kuroishi-site-kuroishi-shi-aomori-jp--fdaest-9614641-2026-09-01)
- [Eizo Corporation (manufacturer, HAKUSAN Ishikawa, JP): 3 new FDA device listings, incl. display, diagnostic radiology](/report/deviceestablishmentpulse/eizo-corporation-hakusan-ishikawa-jp--fdaest-3000237660-2026-09-14)
- [Fujifilm Corporation (manufacturer, ASHIGARAKAMI-GUN Kanagawa, JP): 14 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/fujifilm-corporation-ashigarakami-gun-kanagawa-jp--fdaest-3001722928-2026-08-28)
- [FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa (manufacturer, KASHIWA-SHI Chiba, JP): 3 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/fujifilm-corporation-medical-systems-research-and-kashiwa-shi-chiba-jp--fdaest-3018423337-2026-09-22)
- [FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama (manufacturer, Minato Tokyo, JP): 3 new FDA device listings, incl. lung computed tomography system, computer-aided detection](/report/deviceestablishmentpulse/fujifilm-corporation-medical-systems-research-and-minato-tokyo-jp--fdaest-3005930550-2026-05-29)
- [FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office (manufacturer, HANAMAKI-SHI Iwate, JP): 10 new FDA device listings, incl. gastrointesinal lesion software detection system](/report/deviceestablishmentpulse/fujifilm-healthcare-manufacturing-corporation-hanamaki-hanamaki-shi-iwate-jp--fdaest-3003775006-2026-08-28)
- [FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office (manufacturer, Kashiwa-shi Chiba, JP): 3 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/fujifilm-healthcare-manufacturing-corporation-kashiwa-kashiwa-shi-chiba-jp--fdaest-3032109225-2026-09-22)
- [FUJIFILM Healthcare Manufacturing Corporation Sano Office (manufacturer, Sano City Tochigi, JP): 8 new FDA device listings, incl. led light source](/report/deviceestablishmentpulse/fujifilm-healthcare-manufacturing-corporation-sano-office-sano-city-tochigi-jp--fdaest-3006161756-2026-07-14)
- [Gc Corp. (manufacturer, ITABASHI-KU Tokyo, JP): 2 new FDA device listings, incl. cement, dental](/report/deviceestablishmentpulse/gc-corp-itabashi-ku-tokyo-jp--fdaest-9612300-2026-09-28)
- [Gc Dental Products Corp. (manufacturer, KASUGAI-SHI Aichi, JP): 3 new FDA device listings, incl. material, tooth shade, resin](/report/deviceestablishmentpulse/gc-dental-products-corp-kasugai-shi-aichi-jp--fdaest-9613953-2026-06-25)
- [GE Healthcare Japan Corporation (manufacturer, HINO-SHI Tokyo, JP): 19 new FDA device listings, incl. automated radiological image processing software](/report/deviceestablishmentpulse/ge-healthcare-japan-corporation-hino-shi-tokyo-jp--fdaest-9612283-2026-10-07)
- [Iox Co. Ltd. (manufacturer, Fukui City, JP): 3 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)](/report/deviceestablishmentpulse/iox-co-ltd-fukui-city-jp--fdaest-3045824817-2026-06-02)
- [Japan Gas Company Limited (contract sterilizer, YOKOHAMA Kanagawa, JP): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/japan-gas-company-limited-yokohama-kanagawa-jp--fdaest-3010188783-2026-08-26)
- [Koga Isotope Ltd. (contract sterilizer, Koka-shi Shiga, JP): 2 new FDA device listings, incl. protective coating, mucoadhesive application, for the rectal mucosa](/report/deviceestablishmentpulse/koga-isotope-ltd-koka-shi-shiga-jp--fdaest-3002807408-2026-08-17)
- [Menicon Co. Ltd. (other, NAGOYA Aichi, JP): 2 new FDA device listings, incl. lenses, soft contact, daily wear](/report/deviceestablishmentpulse/menicon-co-ltd-nagoya-aichi-jp--fdaest-9614761-2026-09-23)
- [MENICON CO. LTD. Global Logistics Center (repackager or relabeler, Yachiyo Chiba, JP): 2 new FDA device listings, incl. lenses, soft contact, daily wear](/report/deviceestablishmentpulse/menicon-co-ltd-global-logistics-center-yachiyo-chiba-jp--fdaest-3033524682-2026-09-23)
- [Menicon Co., Ltd., Kakamigahara Plant (manufacturer, Kakamigahara Gifu, JP): 2 new FDA device listings, incl. lenses, soft contact, daily wear](/report/deviceestablishmentpulse/menicon-co-ltd-kakamigahara-plant-kakamigahara-gifu-jp--fdaest-3014768085-2026-09-23)
- [Menicon Co., Ltd., R&D Center (specification developer, Kasugai Aichi, JP): 2 new FDA device listings, incl. lenses, soft contact, daily wear](/report/deviceestablishmentpulse/menicon-co-ltd-r-and-d-center-kasugai-aichi-jp--fdaest-3003062331-2026-09-23)
- [Nihon Kohden Corp. (specification developer, SHINJUKU-KU Tokyo, JP): 5 new FDA device listings, incl. standard polysomnograph with electroencephalograph](/report/deviceestablishmentpulse/nihon-kohden-corp-shinjuku-ku-tokyo-jp--fdaest-9611252-2026-08-06)
- [Nihon Kohden Corporation - Eastern Japan Logistics Center (foreign exporter, Sakado City Saitama, JP): 4 new FDA device listings, incl. standard polysomnograph with electroencephalograph](/report/deviceestablishmentpulse/nihon-kohden-corporation-eastern-japan-logistics-center-sakado-city-saitama-jp--fdaest-3016852448-2026-08-06)
- [Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center (specification developer, Tokorozawa Saitama, JP): 5 new FDA device listings, incl. tape and bandage, adhesive](/report/deviceestablishmentpulse/nihon-kohden-corporation-tokorozawa-establishment-advanced-tokorozawa-saitama-jp--fdaest-3013501110-2026-08-06)
- [Nihon Kohden Tomioka Corporation (manufacturer, Gunma Tokyo, JP): 4 new FDA device listings, incl. standard polysomnograph with electroencephalograph](/report/deviceestablishmentpulse/nihon-kohden-tomioka-corporation-gunma-tokyo-jp--fdaest-3007962724-2026-08-06)
- [Nipro Corporation (foreign exporter, Settsu Osaka, JP): 4 new FDA device listings, incl. syringe, balloon inflation, exempt](/report/deviceestablishmentpulse/nipro-corporation-settsu-osaka-jp--fdaest-3000247873-2026-08-19)
- [Okamoto Industries, Inc. (contract manufacturer, Ryugasaki-Shi, Ibaraki-Pref, JP): 3 new FDA device listings, incl. condom](/report/deviceestablishmentpulse/okamoto-industries-inc-ryugasaki-shi-ibaraki-pref-jp--fdaest-3006122980-2026-09-18)
- [Olympus Medical Systems Corp. (specification developer, HACHIOJI-SHI Tokyo, JP): 20 new FDA device listings, incl. endoscope, accessories, narrow band spectrum](/report/deviceestablishmentpulse/olympus-medical-systems-corp-hachioji-shi-tokyo-jp--fdaest-8010047-2026-10-15)
- [OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant (manufacturer, NISHITAMA-GUN Tokyo, JP): 2 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/olympus-medical-systems-corp-hinode-plant-nishitama-gun-tokyo-jp--fdaest-3003637092-2026-08-31)
- [Shirakawa Olympus Co., Ltd. (manufacturer, NISHISHIRAKAWA-GUN Fukushima, JP): 6 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/shirakawa-olympus-co-ltd-nishishirakawa-gun-fukushima-jp--fdaest-3002808148-2026-09-13)
- [Topcon Corp. (specification developer, Tokyo, JP): 2 new FDA device listings, incl. camera, ophthalmic, slit-scanning](/report/deviceestablishmentpulse/topcon-corp-tokyo-jp--fdaest-9614661-2026-09-25)
- [Topcon Yamagata Co., LTD (contract manufacturer, Yamagata-KEN, JP): 2 new FDA device listings, incl. camera, ophthalmic, slit-scanning](/report/deviceestablishmentpulse/topcon-yamagata-co-ltd-yamagata-ken-jp--fdaest-3008729548-2026-09-25)

## Kansas

- [Remel, Inc. (other, Lenexa, KS): 3 new FDA device listings, incl. transport systems, anaerobic](/report/deviceestablishmentpulse/remel-inc-lenexa-ks--fdaest-1924669-2026-07-15)

## Kentucky

- [Aura Wellness, LLC (manufacturer, Louisville, KY): 2 new FDA device listings, incl. electromagnetic stimulator for healthy muscle stimulation](/report/deviceestablishmentpulse/aura-wellness-llc-louisville-ky--fdaest-3018608545-2026-09-11)
- [Bruno Vision Care LLC (repackager or relabeler, Hebron, KY): 4 new FDA device listings, incl. lenses, soft contact, daily wear](/report/deviceestablishmentpulse/bruno-vision-care-llc-hebron-ky--fdaest-3048183058-2026-07-22)
- [Stephens Instruments, Inc (repackager or relabeler, Lexington, KY): 13 new FDA device listings, incl. spoon, ophthalmic](/report/deviceestablishmentpulse/stephens-instruments-inc-lexington-ky--fdaest-1045379-2026-07-01)
- [UPS Supply Chain Solutions, Inc. (repackager or relabeler, Fairdale, KY): 4 new FDA device listings, incl. visual, pregnancy hcg, prescription use](/report/deviceestablishmentpulse/ups-supply-chain-solutions-inc-fairdale-ky--fdaest-3019946577-2026-08-20)
- [Ups Supply Chain Solutions, Inc. (repackager or relabeler, Louisville, KY): 3 new FDA device listings, incl. enzyme linked immunoabsorbent assay, rubeola igg](/report/deviceestablishmentpulse/ups-supply-chain-solutions-inc-louisville-ky--fdaest-3009171251-2026-06-23)

## KH

- [Camedical Technology (Cambodia) Co., Ltd. (contract manufacturer, Samraong Takeo, KH): 8 new FDA device listings, incl. system, blood collection, vacuum-assisted, manual](/report/deviceestablishmentpulse/camedical-technology-cambodia-co-ltd-samraong-takeo-kh--fdaest-3038294399-2026-07-22)
- [Jumao Medical Equipment (Cambodia) Co., Ltd. (contract manufacturer, Angk Snuol Kandal, KH): 2 new FDA device listings, incl. generator, oxygen, portable](/report/deviceestablishmentpulse/jumao-medical-equipment-cambodia-co-ltd-angk-snuol-kandal-kh--fdaest-3038189860-2026-09-28)
- [Rens Medcare (Cambodia) Co.,Ltd. (manufacturer, Sihanouk Preah Sihanouk, KH): 3 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive](/report/deviceestablishmentpulse/rens-medcare-cambodia-co-ltd-sihanouk-preah-sihanouk-kh--fdaest-3024790242-2026-09-01)

## KR

- [AIRS Medical Inc. (manufacturer, Seoul, KR): 4 new FDA device listings, incl. automated radiological image processing software](/report/deviceestablishmentpulse/airs-medical-inc-seoul-kr--fdaest-3024820186-2026-10-13)
- [Alpha AI Co., Ltd. (manufacturer, PYEONGTAEK Gyeonggi, KR): 4 new FDA device listings, incl. thoracolumbosacral pedicle screw system](/report/deviceestablishmentpulse/alpha-ai-co-ltd-pyeongtaek-gyeonggi-kr--fdaest-3004941535-2026-06-12)
- [Boditech Med Inc. (manufacturer, Chuncheon Gangwon, KR): 9 new FDA device listings, incl. antigens, all groups, streptococcus spp.](/report/deviceestablishmentpulse/boditech-med-inc-chuncheon-gangwon-kr--fdaest-3009491259-2026-09-07)
- [DRTECH Corporation (manufacturer, Seongnam-si Gyeonggi, KR): 4 new FDA device listings, incl. interventional fluoroscopic x-ray system](/report/deviceestablishmentpulse/drtech-corporation-seongnam-si-gyeonggi-kr--fdaest-3005172103-2026-09-10)
- [Edgecare Inc. (manufacturer, Yeongdeungpo-gu Seoul, KR): 4 new FDA device listings, incl. automated radiological image processing software](/report/deviceestablishmentpulse/edgecare-inc-yeongdeungpo-gu-seoul-kr--fdaest-3031569584-2026-06-10)
- [Endorobotics Co., Ltd. (manufacturer, Seoul, KR): 3 new FDA device listings, incl. colonoscope and accessories, flexible/rigid](/report/deviceestablishmentpulse/endorobotics-co-ltd-seoul-kr--fdaest-3044545674-2026-07-13)
- [Hi Medical Co., Ltd. (foreign exporter, Seoul, KR): 4 new FDA device listings, incl. agent, polishing, abrasive, oral cavity](/report/deviceestablishmentpulse/hi-medical-co-ltd-seoul-kr--fdaest-3012502601-2026-07-15)
- [Hironic Co., Ltd. (manufacturer, Yongin-Si Gyeonggi, KR): 2 new FDA device listings, incl. brush, dermabrasion, powered](/report/deviceestablishmentpulse/hironic-co-ltd-yongin-si-gyeonggi-kr--fdaest-3014980461-2026-09-09)
- [Hlb Life Science Co., Ltd. (manufacturer, Anseong-si, Gyeonggi-do, KR): 3 new FDA device listings, incl. low dead space piston syringe](/report/deviceestablishmentpulse/hlb-life-science-co-ltd-anseong-si-gyeonggi-do-kr--fdaest-3030089798-2026-06-11)
- [Hydrochem Co., Ltd (contract manufacturer, Gangeung-Si Gangwon, KR): 7 new FDA device listings, incl. generator, oxygen, portable](/report/deviceestablishmentpulse/hydrochem-co-ltd-gangeung-si-gangwon-kr--fdaest-3045816954-2026-05-19)
- [Jeisys Medical Inc. (manufacturer, Seoul, KR): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/jeisys-medical-inc-seoul-kr--fdaest-3006985163-2026-09-22)
- [Kbbio Co., Ltd. (manufacturer, Seongnam Gyeonggi, KR): 3 new FDA device listings, incl. respirator, surgical](/report/deviceestablishmentpulse/kbbio-co-ltd-seongnam-gyeonggi-kr--fdaest-3017608802-2026-06-17)
- [L&K Biomed Co.,Ltd. (manufacturer, Yongin-SI Gyeonggi, KR): 7 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical](/report/deviceestablishmentpulse/l-and-k-biomed-co-ltd-yongin-si-gyeonggi-kr--fdaest-3008285983-2026-08-20)
- [Medexel Co., Ltd. (contract manufacturer, Anseong-si Gyeonggi, KR): 3 new FDA device listings, incl. syringe, antistick](/report/deviceestablishmentpulse/medexel-co-ltd-anseong-si-gyeonggi-kr--fdaest-3003589279-2026-08-27)
- [Mediclus Co., Ltd (manufacturer, Cheongju-si Chungbuk, KR): 6 new FDA device listings, incl. liner, cavity, calcium hydroxide](/report/deviceestablishmentpulse/mediclus-co-ltd-cheongju-si-chungbuk-kr--fdaest-3013584861-2026-08-24)
- [Miracell Co.,Ltd. (manufacturer, Seongnam-si Gyeonggi, KR): 3 new FDA device listings, incl. centrifuge for preparation of cell concentrate and/or plasma concentra](/report/deviceestablishmentpulse/miracell-co-ltd-seongnam-si-gyeonggi-kr--fdaest-3023346439-2026-09-30)
- [Nanoentek Inc (manufacturer, Hwaseong Gyeonggi, KR): 3 new FDA device listings, incl. radioimmunoassay, total triiodothyronine](/report/deviceestablishmentpulse/nanoentek-inc-hwaseong-gyeonggi-kr--fdaest-3007349751-2026-07-27)
- [Nanoentek Inc (specification developer, Seoul, KR): 3 new FDA device listings, incl. counter, differential cell](/report/deviceestablishmentpulse/nanoentek-inc-seoul-kr--fdaest-3009092698-2026-07-27)
- [Neurophet, Inc. (manufacturer, Seoul, KR): 4 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/neurophet-inc-seoul-kr--fdaest-3025602618-2026-05-20)
- [Osstem Implant Co., Ltd. (specification developer, Gangseo-gu Seoul, KR): 2 new FDA device listings, incl. unit, operative dental](/report/deviceestablishmentpulse/osstem-implant-co-ltd-gangseo-gu-seoul-kr--fdaest-3031886796-2026-09-14)
- [Osstem Implant Co.,Ltd. (manufacturer, Yeonsu-gu Incheon, KR): 11 new FDA device listings, incl. chair, dental, with operative unit](/report/deviceestablishmentpulse/osstem-implant-co-ltd-yeonsu-gu-incheon-kr--fdaest-3045816948-2026-05-13)
- [Samsung Electronics Co., Ltd. Mobile eXperience Business (manufacturer, Suwon-si Gyeonggi, KR): 3 new FDA device listings, incl. over-the-counter device to assess risk of sleep apnea](/report/deviceestablishmentpulse/samsung-electronics-co-ltd-mobile-experience-business-suwon-si-gyeonggi-kr--fdaest-3017616353-2026-08-18)
- [Samsung Medison Co., Ltd. (manufacturer, Gumi-si Gyeongbuk, KR): 13 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic](/report/deviceestablishmentpulse/samsung-medison-co-ltd-gumi-si-gyeongbuk-kr--fdaest-3009758186-2026-10-14)
- [Samsung Medison Co., Ltd. (manufacturer, HONGCHEON-GUN Gangwon, KR): 13 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic](/report/deviceestablishmentpulse/samsung-medison-co-ltd-hongcheon-gun-gangwon-kr--fdaest-8041160-2026-10-14)
- [ShenB Co Ltd (manufacturer, Seongdong-gu Seoul, KR): 5 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/shenb-co-ltd-seongdong-gu-seoul-kr--fdaest-3010226575-2026-08-06)
- [Siemens Healthineers Ltd. (manufacturer, Pohang-si Gyeongbuk, KR): 7 new FDA device listings, incl. catheter, ultrasound, intravascular](/report/deviceestablishmentpulse/siemens-healthineers-ltd-pohang-si-gyeongbuk-kr--fdaest-3006985147-2026-09-14)
- [Siemens Healthineers Ltd. (specification developer, SEONGNAM-SI Gyeonggi, KR): 6 new FDA device listings, incl. biopsy needle guide kit](/report/deviceestablishmentpulse/siemens-healthineers-ltd-seongnam-si-gyeonggi-kr--fdaest-3002619337-2026-06-17)
- [Spident Co., Ltd. (manufacturer, INCHEON Gyeonggi, KR): 2 new FDA device listings, incl. resin, root canal filling](/report/deviceestablishmentpulse/spident-co-ltd-incheon-gyeonggi-kr--fdaest-3006113314-2026-09-13)
- [WEERO Co., Ltd. (manufacturer, Suwon-si,Gyeonggi-do, KR): 3 new FDA device listings, incl. pad, heating, powered](/report/deviceestablishmentpulse/weero-co-ltd-suwon-si-gyeonggi-do-kr--fdaest-3016087653-2026-06-10)
- [Zapalign Inc. (foreign exporter, Anyang-si Gyeonggi, KR): 20 new FDA device listings, incl. agent, tooth bonding, resin](/report/deviceestablishmentpulse/zapalign-inc-anyang-si-gyeonggi-kr--fdaest-3011944170-2026-09-16)
- [Zeros Co., Ltd. (manufacturer, Gimhae-si Gyeongnam, KR): 2 new FDA device listings, incl. implant, endosseous, root-form](/report/deviceestablishmentpulse/zeros-co-ltd-gimhae-si-gyeongnam-kr--fdaest-3032439351-2026-08-24)
- [Zimmer Biomet Korea Ltd. (foreign exporter, Seoul, KR): 8 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or](/report/deviceestablishmentpulse/zimmer-biomet-korea-ltd-seoul-kr--fdaest-3015542154-2026-08-13)

## Louisiana

- [PRIMED Laos Medical Products Manufacturing Sole Co., Ltd. (manufacturer, Vientiane Capital Viangchan(Prefecture), LA): 2 new FDA device listings, incl. medical gowns with chemotherapy labeling claims - tested for use with](/report/deviceestablishmentpulse/primed-laos-medical-products-manufacturing-sole-co-ltd-vientiane-capital-viangchan-pr-la--fdaest-3020755815-2026-09-21)

## LV

- [Light Guide Optics International Ltd. (contract manufacturer, Livani Preilu Novads, LV): 2 new FDA device listings, incl. catheter, peripheral, atherectomy](/report/deviceestablishmentpulse/light-guide-optics-international-ltd-livani-preilu-novads-lv--fdaest-3012669557-2026-08-21)
- [Lsez Sia Lauma Medical / Lauma Medical Lsez LLC (contract manufacturer, Liepaja, LV): 5 new FDA device listings, incl. splint, hand, and components](/report/deviceestablishmentpulse/lsez-sia-lauma-medical-lauma-medical-lsez-llc-liepaja-lv--fdaest-3025771183-2026-07-15)

## Maine

- [LGC Clinical Diagnostics, Inc. (manufacturer, Cumberland Foreside, ME): 2 new FDA device listings, incl. urinalysis controls (assayed and unassayed)](/report/deviceestablishmentpulse/lgc-clinical-diagnostics-inc-cumberland-foreside-me--fdaest-1226774-2026-09-03)

## Maryland

- [Congruence Medical Solutions, LLC (specification developer, Baltimore, MD): 2 new FDA device listings, incl. ophthalmic syringe](/report/deviceestablishmentpulse/congruence-medical-solutions-llc-baltimore-md--fdaest-3014623935-2026-08-20)
- [Imex, LLC (manufacturer, Fulton, MD): 10 new FDA device listings, incl. electrode, cutaneous](/report/deviceestablishmentpulse/imex-llc-fulton-md--fdaest-3030151584-2026-05-06)
- [Maxim Biomedical Inc. (contract manufacturer, Rockville, MD): 2 new FDA device listings, incl. visual, pregnancy hcg, prescription use](/report/deviceestablishmentpulse/maxim-biomedical-inc-rockville-md--fdaest-1122236-2026-10-08)

## Massachusetts

- [3-D Matrix, Inc. (manufacturer, Newton, MA): 4 new FDA device listings, incl. hemostatic device for endoscopic gastrointestinal use](/report/deviceestablishmentpulse/3-d-matrix-inc-newton-ma--fdaest-3015528146-2026-08-14)
- [Access Vascular, Inc (manufacturer, Billerica, MA): 3 new FDA device listings, incl. catheter, intravascular, therapeutic, long-term greater than 30 days](/report/deviceestablishmentpulse/access-vascular-inc-billerica-ma--fdaest-3021570645-2026-06-09)
- [AngioDynamics, Inc. (specification developer, Marlborough, MA): 3 new FDA device listings, incl. system, ablation, microwave and accessories](/report/deviceestablishmentpulse/angiodynamics-inc-marlborough-ma--fdaest-1000523114-2026-07-16)
- [Anika Therapeutics, Inc. (manufacturer, Bedford, MA): 2 new FDA device listings, incl. absorbable synthetic wound dressing](/report/deviceestablishmentpulse/anika-therapeutics-inc-bedford-ma--fdaest-3007093114-2026-09-30)
- [Anumana Inc. (manufacturer, Cambridge, MA): 2 new FDA device listings, incl. cardiac amyloidosis machine learning-based notification software](/report/deviceestablishmentpulse/anumana-inc-cambridge-ma--fdaest-3029762850-2026-10-07)
- [Beacon Biosignals, Inc. (manufacturer, Boston, MA): 3 new FDA device listings, incl. standard polysomnograph with electroencephalograph](/report/deviceestablishmentpulse/beacon-biosignals-inc-boston-ma--fdaest-3027726372-2026-10-16)
- [Bicon, LLC (specification developer, Boston, MA): 2 new FDA device listings, incl. drill, dental, intraoral](/report/deviceestablishmentpulse/bicon-llc-boston-ma--fdaest-1223843-2026-09-29)
- [Boston Scientific Corp., Marina Bay Cust. Fulfillment Center (manufacturer, Quincy, MA): 6 new FDA device listings, incl. unit, electrosurgical, endoscopic (with or without accessories)](/report/deviceestablishmentpulse/boston-scientific-corp-marina-bay-cust-fulfillment-center-quincy-ma--fdaest-1225687-2026-10-16)
- [Boston Scientific Corporation (specification developer, Marlborough, MA): 9 new FDA device listings, incl. ureteroscope and accessories, flexible/rigid](/report/deviceestablishmentpulse/boston-scientific-corporation-marlborough-ma--fdaest-3005099803-2026-10-16)
- [Butterfly Network, Inc. (specification developer, Burlington, MA): 4 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/butterfly-network-inc-burlington-ma--fdaest-3010102386-2026-09-11)
- [Comforback Inc (specification developer, Auburndale, MA): 4 new FDA device listings, incl. orthosis, cervical](/report/deviceestablishmentpulse/comforback-inc-auburndale-ma--fdaest-3024755175-2026-05-27)
- [Depuy Orthopaedics, Inc. (manufacturer, Raynham, MA): 4 new FDA device listings, incl. prosthesis, knee, patello/femorotibial, semi-constrained, uncemented,](/report/deviceestablishmentpulse/depuy-orthopaedics-inc-raynham-ma--fdaest-1219655-2026-09-24)
- [Draeger Medical Systems, Inc. (manufacturer, Andover, MA): 17 new FDA device listings, incl. continuous measurement thermometer](/report/deviceestablishmentpulse/draeger-medical-systems-inc-andover-ma--fdaest-3005783425-2026-09-11)
- [E. Benson Hood Laboratories, Inc. (manufacturer, Pembroke, MA): 13 new FDA device listings, incl. bronchoscope (flexible or rigid)](/report/deviceestablishmentpulse/e-benson-hood-laboratories-inc-pembroke-ma--fdaest-1220850-2026-06-03)
- [FUJIFILM Healthcare Americas Corporation (manufacturer, Lexington, MA): 9 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic](/report/deviceestablishmentpulse/fujifilm-healthcare-americas-corporation-lexington-ma--fdaest-1000513161-2026-09-30)
- [Isomedix Operations Inc. (contract sterilizer, Northborough, MA): 18 new FDA device listings, incl. introducer, catheter](/report/deviceestablishmentpulse/isomedix-operations-inc-northborough-ma--fdaest-1220477-2026-09-25)
- [Karl Storz Endoscopy-America, Inc. (repackager or relabeler, Auburn, MA): 14 new FDA device listings, incl. hysteroscope (and accessories)](/report/deviceestablishmentpulse/karl-storz-endoscopy-america-inc-auburn-ma--fdaest-2020550-2026-09-28)
- [Kaz USA, Inc., A Helen of Troy Company (specification developer, Marlborough, MA): 4 new FDA device listings, incl. clinical electronic thermometer](/report/deviceestablishmentpulse/kaz-usa-inc-a-helen-of-troy-company-marlborough-ma--fdaest-3006169981-2026-06-23)
- [LGC Clinical Diagnostics, Inc. (manufacturer, Milford, MA): 2 new FDA device listings, incl. equipment, laboratory, general purpose, labeled or promoted for a spec](/report/deviceestablishmentpulse/lgc-clinical-diagnostics-inc-milford-ma--fdaest-3007088335-2026-09-03)
- [Menicon America, Inc. (repackager or relabeler, North Billerica, MA): 2 new FDA device listings, incl. lenses, soft contact, daily wear](/report/deviceestablishmentpulse/menicon-america-inc-north-billerica-ma--fdaest-3003515967-2026-09-23)
- [Millstone Medical Outsourcing LLC. (contract manufacturer, Fall River, MA): 24 new FDA device listings, incl. peripheral blood processing device for wound management](/report/deviceestablishmentpulse/millstone-medical-outsourcing-llc-fall-river-ma--fdaest-1226544-2026-10-08)
- [Myriad Fiber Imaging Technologies, Inc. (contract manufacturer, Dudley, MA): 2 new FDA device listings, incl. insufflator, laparoscopic](/report/deviceestablishmentpulse/myriad-fiber-imaging-technologies-inc-dudley-ma--fdaest-1225984-2026-09-11)
- [Nanoentek America, Inc (other, North Waltham, MA): 3 new FDA device listings, incl. radioimmunoassay, total triiodothyronine](/report/deviceestablishmentpulse/nanoentek-america-inc-north-waltham-ma--fdaest-3007113174-2026-07-27)
- [NanoHive Medical LLC (manufacturer, Woburn, MA): 3 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical](/report/deviceestablishmentpulse/nanohive-medical-llc-woburn-ma--fdaest-3013462427-2026-05-08)
- [Normatec Industries, LP (specification developer, Watertown, MA): 2 new FDA device listings, incl. pad, heating, powered](/report/deviceestablishmentpulse/normatec-industries-lp-watertown-ma--fdaest-3003619590-2026-10-15)
- [Pascall Systems Inc (manufacturer, Cambridge, MA): 4 new FDA device listings, incl. reduced- montage standard electroencephalograph](/report/deviceestablishmentpulse/pascall-systems-inc-cambridge-ma--fdaest-3024892936-2026-08-21)
- [Performance Fibers OEM LLC (contract manufacturer, Mansfield, MA): 58 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene](/report/deviceestablishmentpulse/performance-fibers-oem-llc-mansfield-ma--fdaest-1221601-2026-08-17)
- [Philips North America LLC (other, Cambridge, MA): 62 new FDA device listings, incl. monitor, cardiac (incl. cardiotachometer & rate alarm)](/report/deviceestablishmentpulse/philips-north-america-llc-cambridge-ma--fdaest-3016618143-2026-05-22)
- [Primo Medical Group, INC (contract manufacturer, Stoughton, MA): 2 new FDA device listings, incl. fastener, fixation, nondegradable, soft tissue](/report/deviceestablishmentpulse/primo-medical-group-inc-stoughton-ma--fdaest-1222928-2026-09-21)
- [Siemens Healthcare Diagnostics Inc. (manufacturer, E Walpole, MA): 5 new FDA device listings, incl. test, prostate specific antigen, free, (noncomplexed) to distinguish p](/report/deviceestablishmentpulse/siemens-healthcare-diagnostics-inc-e-walpole-ma--fdaest-1219913-2026-08-27)
- [Spectrawave, Inc. (manufacturer, Bedford, MA): 17 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/spectrawave-inc-bedford-ma--fdaest-3017654247-2026-06-16)
- [Tecomet Inc. (contract manufacturer, Wilmington, MA): 3 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, cemented](/report/deviceestablishmentpulse/tecomet-inc-wilmington-ma--fdaest-1225675-2026-10-15)

## Michigan

- [Biopro, Inc. (contract manufacturer, Port Huron, MI): 11 new FDA device listings, incl. system, skin closure](/report/deviceestablishmentpulse/biopro-inc-port-huron-mi--fdaest-1833506-2026-10-15)
- [Greystone Medical, LLC (specification developer, Waterford, MI): 6 new FDA device listings, incl. needle, hypodermic, single lumen](/report/deviceestablishmentpulse/greystone-medical-llc-waterford-mi--fdaest-3015176887-2026-07-20)
- [Indica-Mcs LLC (contract manufacturer, Fowlerville, MI): 3 new FDA device listings, incl. surgical table cushion](/report/deviceestablishmentpulse/indica-mcs-llc-fowlerville-mi--fdaest-3013721938-2026-05-13)
- [J Sterling Industries LLC (contract manufacturer, Kalamazoo, MI): 4 new FDA device listings, incl. holder, needle; orthopedic](/report/deviceestablishmentpulse/j-sterling-industries-llc-kalamazoo-mi--fdaest-3008879776-2026-06-18)
- [Materialise USA, LLC. (manufacturer, Plymouth, MI): 3 new FDA device listings, incl. shoulder arthroplasty implantation system](/report/deviceestablishmentpulse/materialise-usa-llc-plymouth-mi--fdaest-3005718816-2026-07-08)
- [MC3, Inc. (specification developer, Dexter, MI): 4 new FDA device listings, incl. extracorporeal system for long-term respiratory / cardiopulmonary fail](/report/deviceestablishmentpulse/mc3-inc-dexter-mi--fdaest-3011468686-2026-08-26)
- [Moebius Precision Corp (contract manufacturer, Lansing, MI): 4 new FDA device listings, incl. fastener, fixation, nondegradable, soft tissue](/report/deviceestablishmentpulse/moebius-precision-corp-lansing-mi--fdaest-3021902344-2026-08-04)
- [Packaging Compliance Medical, LLC (contract manufacturer, Kentwood, MI): 10 new FDA device listings, incl. guide, surgical, instrument](/report/deviceestablishmentpulse/packaging-compliance-medical-llc-kentwood-mi--fdaest-3014967969-2026-05-27)
- [Pioneer Surgical Technology, Inc. (contract manufacturer, Marquette, MI): 9 new FDA device listings, incl. cerclage, fixation](/report/deviceestablishmentpulse/pioneer-surgical-technology-inc-marquette-mi--fdaest-1833824-2026-08-10)
- [Precision Edge Surgical Products Company (contract manufacturer, Sault Sainte Marie, MI): 3 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/precision-edge-surgical-products-company-sault-sainte-marie-mi--fdaest-1833986-2026-09-21)
- [Safe N Simple LLC (specification developer, Clarkston, MI): 4 new FDA device listings, incl. dressing, wound, drug](/report/deviceestablishmentpulse/safe-n-simple-llc-clarkston-mi--fdaest-3008374791-2026-09-23)
- [SHOULDER INNOVATIONS, Inc (specification developer, Grand Rapids, MI): 7 new FDA device listings, incl. prosthesis, shoulder, non-constrained, metal/polymer cemented](/report/deviceestablishmentpulse/shoulder-innovations-inc-grand-rapids-mi--fdaest-3012544635-2026-10-15)
- [SunMed Group Holdings, LLC (specification developer, Grand Rapids, MI): 9 new FDA device listings, incl. blood pressure cuff](/report/deviceestablishmentpulse/sunmed-group-holdings-llc-grand-rapids-mi--fdaest-1314417-2026-08-26)
- [Sws-Trimac, Inc. (contract manufacturer, Saginaw, MI): 2 new FDA device listings, incl. table and attachments, operating-room](/report/deviceestablishmentpulse/sws-trimac-inc-saginaw-mi--fdaest-3005022202-2026-09-24)

## Minnesota

- [Acist Medical Systems, Inc. (manufacturer, Eden Prairie, MN): 3 new FDA device listings, incl. injector and syringe, angiographic](/report/deviceestablishmentpulse/acist-medical-systems-inc-eden-prairie-mn--fdaest-2134243-2026-08-05)
- [Benchmark Electronics, Inc. (contract manufacturer, Rochester, MN): 4 new FDA device listings, incl. unit, operative dental](/report/deviceestablishmentpulse/benchmark-electronics-inc-rochester-mn--fdaest-2133786-2026-09-14)
- [Boston Scientific Corporation (manufacturer, Saint Paul, MN): 24 new FDA device listings, incl. powered laser surgical instrument](/report/deviceestablishmentpulse/boston-scientific-corporation-saint-paul-mn--fdaest-2124215-2026-10-16)
- [Boston Scientific Corporation (specification developer, Maple Grove, MN): 8 new FDA device listings, incl. catheter, continuous flush](/report/deviceestablishmentpulse/boston-scientific-corporation-maple-grove-mn--fdaest-2134265-2026-09-22)
- [COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen (contract manufacturer, Eden Prairie, MN): 3 new FDA device listings, incl. bone grafting material, animal source](/report/deviceestablishmentpulse/collagen-solutions-tissx-llc-d-b-a-evergen-eden-prairie-mn--fdaest-3014003617-2026-07-17)
- [EarGear LLC (specification developer, Eden Prairie, MN): 4 new FDA device listings, incl. prosthesis, adhesive, external](/report/deviceestablishmentpulse/eargear-llc-eden-prairie-mn--fdaest-3047515274-2026-07-02)
- [EPIC MedTec OEM Catheter & Wire LLC (contract manufacturer, Plymouth, MN): 14 new FDA device listings, incl. introducer, catheter](/report/deviceestablishmentpulse/epic-medtec-oem-catheter-and-wire-llc-plymouth-mn--fdaest-3005232773-2026-09-24)
- [Fiagon Na LLC (manufacturer, Saint Paul, MN): 3 new FDA device listings, incl. balloon, nasal airway](/report/deviceestablishmentpulse/fiagon-na-llc-saint-paul-mn--fdaest-3025490805-2026-09-02)
- [GN Hearing Care Corporation (other, Shakopee, MN): 2 new FDA device listings, incl. self-fitting air-conduction hearing aid, over the counter](/report/deviceestablishmentpulse/gn-hearing-care-corporation-shakopee-mn--fdaest-2182204-2026-08-17)
- [Gt Metabolic Solutions, Inc. (manufacturer, Saint Michael, MN): 2 new FDA device listings, incl. magnetic compression anastomosis system](/report/deviceestablishmentpulse/gt-metabolic-solutions-inc-saint-michael-mn--fdaest-3017462289-2026-09-22)
- [I-Tek Medical, Inc. (contract manufacturer, White Bear Lake, MN): 2 new FDA device listings, incl. cannula, surgical, general & plastic surgery](/report/deviceestablishmentpulse/i-tek-medical-inc-white-bear-lake-mn--fdaest-3008627763-2026-09-21)
- [Isomedix Operations, Inc. (contract sterilizer, Minneapolis, MN): 12 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/isomedix-operations-inc-minneapolis-mn--fdaest-2183744-2026-10-14)
- [MedSource Labs, LLC (manufacturer, Chanhassen, MN): 4 new FDA device listings, incl. catheter, intravascular, therapeutic, short-term less than 30 days](/report/deviceestablishmentpulse/medsource-labs-llc-chanhassen-mn--fdaest-3003674698-2026-07-14)
- [Patterson Dental Supply, Inc. (repackager or relabeler, St. Paul, MN): 5 new FDA device listings, incl. resin, root canal filling](/report/deviceestablishmentpulse/patterson-dental-supply-inc-st-paul-mn--fdaest-2183301-2026-08-04)
- [Piraeus Medical, Inc. (manufacturer, Maple Grove, MN): 4 new FDA device listings, incl. wire, guide, catheter](/report/deviceestablishmentpulse/piraeus-medical-inc-maple-grove-mn--fdaest-3031768596-2026-10-12)
- [Rms Co. (contract manufacturer, Minneapolis, MN): 9 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar](/report/deviceestablishmentpulse/rms-co-minneapolis-mn--fdaest-2183946-2026-08-14)
- [St. Jude Medical, Atrial Fibrillation Division, Inc. (manufacturer, Saint Paul, MN): 3 new FDA device listings, incl. computer, diagnostic, programmable](/report/deviceestablishmentpulse/st-jude-medical-atrial-fibrillation-division-inc-saint-paul-mn--fdaest-2184149-2026-09-18)
- [St. Jude Medical, Cardiology Division, Inc. (manufacturer, Plymouth, MN): 4 new FDA device listings, incl. computer, diagnostic, programmable](/report/deviceestablishmentpulse/st-jude-medical-cardiology-division-inc-plymouth-mn--fdaest-3005334138-2026-09-18)

## Mississippi

- [Kaz USA, Inc., A Helen of Troy Company (repackager or relabeler, Olive Branch, MS): 3 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive](/report/deviceestablishmentpulse/kaz-usa-inc-a-helen-of-troy-company-olive-branch-ms--fdaest-3010405299-2026-06-23)
- [Millstone Medical Outsourcing LLC (contract manufacturer, Olive Branch, MS): 272 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/millstone-medical-outsourcing-llc-olive-branch-ms--fdaest-3010097171-2026-10-15)

## Missouri

- [Biomerieux, Inc. (manufacturer, Hazelwood, MO): 11 new FDA device listings, incl. susceptibility test cards, antimicrobial](/report/deviceestablishmentpulse/biomerieux-inc-hazelwood-mo--fdaest-1950204-2026-09-29)
- [Midwest Sterilization Corp. (contract sterilizer, Jackson, MO): 20 new FDA device listings, incl. stimulator, spinal-cord, implanted (pain relief)](/report/deviceestablishmentpulse/midwest-sterilization-corp-jackson-mo--fdaest-1928237-2026-07-21)
- [Surgical Instrument Manufacturers, LLC (contract manufacturer, Fenton, MO): 13 new FDA device listings, incl. sacroiliac joint fixation](/report/deviceestablishmentpulse/surgical-instrument-manufacturers-llc-fenton-mo--fdaest-1935627-2026-09-25)

## MX

- [HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V. (contract manufacturer, Tijuana Baja California, MX): 30 new FDA device listings, incl. instrument, vitreous aspiration and cutting, ac-powered](/report/deviceestablishmentpulse/harmac-medical-products-inc-h3-de-tijuana-s-de-rl-de-c-v-tijuana-baja-california-mx--fdaest-3045817901-2026-05-27)
- [Medline Industries, LP - Mexicali (MXC) (manufacturer, Mexicali Baja California, MX): 4 new FDA device listings, incl. tubes, vials, systems, serum separators, blood collection](/report/deviceestablishmentpulse/medline-industries-lp-mexicali-mxc-mexicali-baja-california-mx--fdaest-3015173212-2026-06-05)
- [Tutamen De Mexico, LLC (manufacturer, Tijuana Baja California, MX): 4 new FDA device listings, incl. immunoglobulin g (igg) infusion system](/report/deviceestablishmentpulse/tutamen-de-mexico-llc-tijuana-baja-california-mx--fdaest-3013591868-2026-10-16)

## Nevada

- [Eiger Diagnostics, Inc. (manufacturer, Las Vegas, NV): 3 new FDA device listings, incl. device, general purpose, microbiology, diagnostic](/report/deviceestablishmentpulse/eiger-diagnostics-inc-las-vegas-nv--fdaest-3026241718-2026-06-01)
- [Medicreations LLC (repackager or relabeler, Las Vegas, NV): 3 new FDA device listings, incl. powered laser surgical instrument](/report/deviceestablishmentpulse/medicreations-llc-las-vegas-nv--fdaest-3012772112-2026-06-26)
- [Merits Health Products, Inc. (contract manufacturer, Las Vegas, NV): 18 new FDA device listings, incl. wheelchair, powered](/report/deviceestablishmentpulse/merits-health-products-inc-las-vegas-nv--fdaest-3030822491-2026-07-14)
- [Paragon Implant Company, LLC (manufacturer, Las Vegas, NV): 2 new FDA device listings, incl. implant, endosseous, root-form](/report/deviceestablishmentpulse/paragon-implant-company-llc-las-vegas-nv--fdaest-3033708818-2026-09-18)
- [Restore Robotics Repairs LLC (remanufacturer, Henderson, NV): 2 new FDA device listings, incl. system, surgical, computer controlled instrument, remanufactured](/report/deviceestablishmentpulse/restore-robotics-repairs-llc-henderson-nv--fdaest-3036035332-2026-10-16)

## New Hampshire

- [A.M. Surgical, Inc. (specification developer, Nashua, NH): 4 new FDA device listings, incl. tray, surgical, instrument](/report/deviceestablishmentpulse/a-m-surgical-inc-nashua-nh--fdaest-2437731-2026-06-11)
- [Deka Research & Development Corp. (specification developer, Manchester, NH): 4 new FDA device listings, incl. controller, infusion, intravascular, electronic](/report/deviceestablishmentpulse/deka-research-and-development-corp-manchester-nh--fdaest-1220973-2026-09-25)
- [EPIC MedTec OEM LLC (contract manufacturer, Jaffrey, NH): 2 new FDA device listings, incl. tubes, gastrointestinal (and accessories)](/report/deviceestablishmentpulse/epic-medtec-oem-llc-jaffrey-nh--fdaest-1221019-2026-08-18)
- [Millyard Advanced Medical Products LLC (manufacturer, Manchester, NH): 3 new FDA device listings, incl. insulin pump secondary display](/report/deviceestablishmentpulse/millyard-advanced-medical-products-llc-manchester-nh--fdaest-3016798778-2026-09-25)
- [Revive Regenerative Inc. (other, Nashua, NH): 4 new FDA device listings, incl. massager, vacuum, radio frequency induced heat](/report/deviceestablishmentpulse/revive-regenerative-inc-nashua-nh--fdaest-3038715747-2026-08-21)
- [Symmetry Medical, Inc. - Manchester (contract manufacturer, Manchester, NH): 4 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/symmetry-medical-inc-manchester-manchester-nh--fdaest-1221053-2026-08-23)
- [Venus Concept Inc. (manufacturer, Windham, NH): 7 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/venus-concept-inc-windham-nh--fdaest-3042351542-2026-07-06)

## New Jersey

- [Church & Dwight Co., Inc. (other, Princeton, NJ): 2 new FDA device listings, incl. condom](/report/deviceestablishmentpulse/church-and-dwight-co-inc-princeton-nj--fdaest-2280705-2026-10-07)
- [Diagnostica Stago, Inc. (other, Parsippany, NJ): 6 new FDA device listings, incl. test, time, partial thromboplastin](/report/deviceestablishmentpulse/diagnostica-stago-inc-parsippany-nj--fdaest-2245451-2026-05-28)
- [DRG International, Inc. (repackager or relabeler, Springfield, NJ): 13 new FDA device listings, incl. prostate-specific antigen (psa) for management of prostate cancers](/report/deviceestablishmentpulse/drg-international-inc-springfield-nj--fdaest-2245285-2026-09-16)
- [Dsv Contract Logistics LLC (repackager or relabeler, Port Reading, NJ): 18 new FDA device listings, incl. orthosis, foot drop](/report/deviceestablishmentpulse/dsv-contract-logistics-llc-port-reading-nj--fdaest-3013070831-2026-08-04)
- [Ethicon, Inc. (specification developer, Raritan, NJ): 3 new FDA device listings, incl. suture, absorbable, synthetic, polyglycolic acid](/report/deviceestablishmentpulse/ethicon-inc-raritan-nj--fdaest-3017102971-2026-06-02)
- [Ethos Biosciences, INC. (contract manufacturer, Logan Township, NJ): 4 new FDA device listings, incl. van gieson's stain](/report/deviceestablishmentpulse/ethos-biosciences-inc-logan-township-nj--fdaest-2247035-2026-08-06)
- [Euroimmun Us Inc. (other, Mountain Lakes, NJ): 3 new FDA device listings, incl. extractable antinuclear antibody, antigen and control](/report/deviceestablishmentpulse/euroimmun-us-inc-mountain-lakes-nj--fdaest-3007118747-2026-09-10)
- [Extremity Medical, LLC (specification developer, Parsippany, NJ): 2 new FDA device listings, incl. instrument, surgical, orthopedic, ac-powered motor and accessory/attac](/report/deviceestablishmentpulse/extremity-medical-llc-parsippany-nj--fdaest-3007289093-2026-09-03)
- [FUJIFILM Healthcare Americas Corporation (repackager or relabeler, Edison, NJ): 9 new FDA device listings, incl. single (specified) analyte controls (assayed and unassayed)](/report/deviceestablishmentpulse/fujifilm-healthcare-americas-corporation-edison-nj--fdaest-3005625991-2026-09-09)
- [Howmedica Osteonics Corp (manufacturer, Mahwah, NJ): 11 new FDA device listings, incl. prosthesis, knee, patello/femorotibial, semi-constrained, uncemented,](/report/deviceestablishmentpulse/howmedica-osteonics-corp-mahwah-nj--fdaest-2249697-2026-08-12)
- [Isomedix Operations Inc. (contract sterilizer, S Plainfield, NJ): 16 new FDA device listings, incl. sealant, microbial](/report/deviceestablishmentpulse/isomedix-operations-inc-s-plainfield-nj--fdaest-2246552-2026-09-28)
- [Isomedix Operations Inc. (contract sterilizer, Whippany, NJ): 26 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/isomedix-operations-inc-whippany-nj--fdaest-2245304-2026-09-28)
- [Medin Technologies, Inc. (contract manufacturer, Totowa, NJ): 20 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/medin-technologies-inc-totowa-nj--fdaest-3011296511-2026-06-25)
- [Menasha Packaging Company ,LLC (repackager or relabeler, Edison, NJ): 3 new FDA device listings, incl. condom, synthetic](/report/deviceestablishmentpulse/menasha-packaging-company-llc-edison-nj--fdaest-3003896222-2026-07-28)
- [MINDRAY DS USA, Inc. (contract manufacturer, Mahwah, NJ): 62 new FDA device listings, incl. continuous, minimal ventilatory support, facility use ventilator](/report/deviceestablishmentpulse/mindray-ds-usa-inc-mahwah-nj--fdaest-2221819-2026-09-02)
- [Mouthwatch, Inc. (specification developer, Metuchen, NJ): 2 new FDA device listings, incl. scraper, tongue](/report/deviceestablishmentpulse/mouthwatch-inc-metuchen-nj--fdaest-3012664306-2026-08-20)
- [Roche Molecular Systems, Inc. (manufacturer, Branchburg, NJ): 4 new FDA device listings, incl. vaginitis and bacterial vaginosis nucleic acid detection system](/report/deviceestablishmentpulse/roche-molecular-systems-inc-branchburg-nj--fdaest-2243471-2026-09-10)
- [Topcon Healthcare, Inc. (manufacturer, Oakland, NJ): 9 new FDA device listings, incl. refractometer, ophthalmic](/report/deviceestablishmentpulse/topcon-healthcare-inc-oakland-nj--fdaest-2242863-2026-07-08)
- [UPS Supply Chain Solutions, Inc. (repackager or relabeler, Pedricktown, NJ): 4 new FDA device listings, incl. enzyme linked immunoabsorbent assay, mumps virus](/report/deviceestablishmentpulse/ups-supply-chain-solutions-inc-pedricktown-nj--fdaest-3013718871-2026-06-23)
- [Valmar Surgical Supplies, Inc. (repackager or relabeler, Lakewood, NJ): 8 new FDA device listings, incl. bedding, disposable, medical](/report/deviceestablishmentpulse/valmar-surgical-supplies-inc-lakewood-nj--fdaest-3008771621-2026-10-12)
- [Vision Rx Lab America LLC (remanufacturer, Cranford, NJ): 4 new FDA device listings, incl. spectacle, magnifying](/report/deviceestablishmentpulse/vision-rx-lab-america-llc-cranford-nj--fdaest-3015531880-2026-06-26)
- [Zeus Scientific LLC (manufacturer, Branchburg, NJ): 7 new FDA device listings, incl. extractable antinuclear antibody, antigen and control](/report/deviceestablishmentpulse/zeus-scientific-llc-branchburg-nj--fdaest-2242436-2026-09-01)

## New Mexico

- [Nypro Healthcare Baja Inc. (Albuquerque) (contract manufacturer, Albuquerque, NM): 4 new FDA device listings, incl. staple, implantable](/report/deviceestablishmentpulse/nypro-healthcare-baja-inc-albuquerque-albuquerque-nm--fdaest-3015183635-2026-09-03)
- [Sterigenics U.S., LLC (contract sterilizer, Santa Teresa, NM): 17 new FDA device listings, incl. apron, leaded](/report/deviceestablishmentpulse/sterigenics-u-s-llc-santa-teresa-nm--fdaest-1721686-2026-09-01)

## New York

- [Alc Enterprises Inc (specification developer, Brooklyn, NY): 4 new FDA device listings, incl. over-the-counter powered light based laser for acne](/report/deviceestablishmentpulse/alc-enterprises-inc-brooklyn-ny--fdaest-3011721071-2026-10-18)
- [American Diagnostic Corp. (repackager or relabeler, Hauppauge, NY): 3 new FDA device listings, incl. continuous measurement thermometer](/report/deviceestablishmentpulse/american-diagnostic-corp-hauppauge-ny--fdaest-2434008-2026-06-03)
- [Angiodynamics, Inc (manufacturer, Glens Falls, NY): 3 new FDA device listings, incl. system, ablation, microwave and accessories](/report/deviceestablishmentpulse/angiodynamics-inc-glens-falls-ny--fdaest-3017892510-2026-07-16)
- [Angiodynamics, Inc. (manufacturer, Queensbury, NY): 3 new FDA device listings, incl. system, ablation, microwave and accessories](/report/deviceestablishmentpulse/angiodynamics-inc-queensbury-ny--fdaest-1319211-2026-07-16)
- [Central Assn. For The Blind (repackager or relabeler, Utica, NY): 4 new FDA device listings, incl. medical glove, specialty](/report/deviceestablishmentpulse/central-assn-for-the-blind-utica-ny--fdaest-1319302-2026-09-23)
- [Cogentix Medical, Inc. (manufacturer, Orangeburg, NY): 2 new FDA device listings, incl. cystoscope and accessories, flexible/rigid](/report/deviceestablishmentpulse/cogentix-medical-inc-orangeburg-ny--fdaest-2242464-2026-09-08)
- [Conmed Corporation (other, Utica, NY): 3 new FDA device listings, incl. fastener, fixation, nondegradable, soft tissue](/report/deviceestablishmentpulse/conmed-corporation-utica-ny--fdaest-1320894-2026-09-14)
- [Dukal LLC (specification developer, Ronkonkoma, NY): 3 new FDA device listings, incl. wound dressing with animal-derived material(s)](/report/deviceestablishmentpulse/dukal-llc-ronkonkoma-ny--fdaest-2435946-2026-06-23)
- [Endure Industries, Inc. (specification developer, Homer, NY): 14 new FDA device listings, incl. cannula, nasal, oxygen](/report/deviceestablishmentpulse/endure-industries-inc-homer-ny--fdaest-3013187142-2026-08-11)
- [Harmony Health Tech Inc (repackager or relabeler, Brooklyn, NY): 3 new FDA device listings, incl. massager, powered inflatable tube](/report/deviceestablishmentpulse/harmony-health-tech-inc-brooklyn-ny--fdaest-3037609256-2026-08-06)

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