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).

Indiana

• Zimmer India Private Limited (foreign exporter, Gurugram Haryana, IN): 3 new FDA device listings, incl. prosthesis, knee, patello/femorotibial, semi-constrained, uncemented,
• Zimmer, Inc. (contract manufacturer, Warsaw, IN): 28 new FDA device listings, incl. screw, fixation, bone

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
• Aizu Olympus Co., Ltd. (manufacturer, AIZUWAKAMATSU-SHI Fukushima, JP): 4 new FDA device listings, incl. endoscope, accessories, narrow band spectrum
• 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
• AOMORI OLYMPUS CO., LTD. Kuroishi Site (manufacturer, KUROISHI-SHI Aomori, JP): 6 new FDA device listings, incl. forceps, biopsy, electric
• Eizo Corporation (manufacturer, HAKUSAN Ishikawa, JP): 3 new FDA device listings, incl. display, diagnostic radiology
• Fujifilm Corporation (manufacturer, ASHIGARAKAMI-GUN Kanagawa, JP): 14 new FDA device listings, incl. system, image processing, radiological
• FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa (manufacturer, KASHIWA-SHI Chiba, JP): 3 new FDA device listings, incl. system, x-ray, tomography, computed
• 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
• FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office (manufacturer, HANAMAKI-SHI Iwate, JP): 10 new FDA device listings, incl. gastrointesinal lesion software detection system
• FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office (manufacturer, Kashiwa-shi Chiba, JP): 3 new FDA device listings, incl. system, x-ray, tomography, computed
• FUJIFILM Healthcare Manufacturing Corporation Sano Office (manufacturer, Sano City Tochigi, JP): 8 new FDA device listings, incl. led light source
• Gc Corp. (manufacturer, ITABASHI-KU Tokyo, JP): 2 new FDA device listings, incl. cement, dental
• Gc Dental Products Corp. (manufacturer, KASUGAI-SHI Aichi, JP): 3 new FDA device listings, incl. material, tooth shade, resin
• GE Healthcare Japan Corporation (manufacturer, HINO-SHI Tokyo, JP): 19 new FDA device listings, incl. automated radiological image processing software
• Iox Co. Ltd. (manufacturer, Fukui City, JP): 3 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)
• Japan Gas Company Limited (contract sterilizer, YOKOHAMA Kanagawa, JP): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Koga Isotope Ltd. (contract sterilizer, Koka-shi Shiga, JP): 2 new FDA device listings, incl. protective coating, mucoadhesive application, for the rectal mucosa
• Menicon Co. Ltd. (other, NAGOYA Aichi, JP): 2 new FDA device listings, incl. lenses, soft contact, daily wear
• MENICON CO. LTD. Global Logistics Center (repackager or relabeler, Yachiyo Chiba, JP): 2 new FDA device listings, incl. lenses, soft contact, daily wear
• Menicon Co., Ltd., Kakamigahara Plant (manufacturer, Kakamigahara Gifu, JP): 2 new FDA device listings, incl. lenses, soft contact, daily wear
• Menicon Co., Ltd., R&D Center (specification developer, Kasugai Aichi, JP): 2 new FDA device listings, incl. lenses, soft contact, daily wear
• Nihon Kohden Corp. (specification developer, SHINJUKU-KU Tokyo, JP): 5 new FDA device listings, incl. standard polysomnograph with electroencephalograph
• Nihon Kohden Corporation - Eastern Japan Logistics Center (foreign exporter, Sakado City Saitama, JP): 4 new FDA device listings, incl. standard polysomnograph with electroencephalograph
• Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center (specification developer, Tokorozawa Saitama, JP): 5 new FDA device listings, incl. tape and bandage, adhesive
• Nihon Kohden Tomioka Corporation (manufacturer, Gunma Tokyo, JP): 4 new FDA device listings, incl. standard polysomnograph with electroencephalograph
• Nipro Corporation (foreign exporter, Settsu Osaka, JP): 4 new FDA device listings, incl. syringe, balloon inflation, exempt
• Okamoto Industries, Inc. (contract manufacturer, Ryugasaki-Shi, Ibaraki-Pref, JP): 3 new FDA device listings, incl. condom
• Olympus Medical Systems Corp. (specification developer, HACHIOJI-SHI Tokyo, JP): 20 new FDA device listings, incl. endoscope, accessories, narrow band spectrum
• OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant (manufacturer, NISHITAMA-GUN Tokyo, JP): 2 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Shirakawa Olympus Co., Ltd. (manufacturer, NISHISHIRAKAWA-GUN Fukushima, JP): 6 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Topcon Corp. (specification developer, Tokyo, JP): 2 new FDA device listings, incl. camera, ophthalmic, slit-scanning
• Topcon Yamagata Co., LTD (contract manufacturer, Yamagata-KEN, JP): 2 new FDA device listings, incl. camera, ophthalmic, slit-scanning

Kansas

• Remel, Inc. (other, Lenexa, KS): 3 new FDA device listings, incl. transport systems, anaerobic

Kentucky

• Aura Wellness, LLC (manufacturer, Louisville, KY): 2 new FDA device listings, incl. electromagnetic stimulator for healthy muscle stimulation
• Bruno Vision Care LLC (repackager or relabeler, Hebron, KY): 4 new FDA device listings, incl. lenses, soft contact, daily wear
• Stephens Instruments, Inc (repackager or relabeler, Lexington, KY): 13 new FDA device listings, incl. spoon, ophthalmic
• UPS Supply Chain Solutions, Inc. (repackager or relabeler, Fairdale, KY): 4 new FDA device listings, incl. visual, pregnancy hcg, prescription use
• Ups Supply Chain Solutions, Inc. (repackager or relabeler, Louisville, KY): 3 new FDA device listings, incl. enzyme linked immunoabsorbent assay, rubeola igg

KH

• Camedical Technology (Cambodia) Co., Ltd. (contract manufacturer, Samraong Takeo, KH): 8 new FDA device listings, incl. system, blood collection, vacuum-assisted, manual
• Jumao Medical Equipment (Cambodia) Co., Ltd. (contract manufacturer, Angk Snuol Kandal, KH): 2 new FDA device listings, incl. generator, oxygen, portable
• Rens Medcare (Cambodia) Co.,Ltd. (manufacturer, Sihanouk Preah Sihanouk, KH): 3 new FDA device listings, incl. system, measurement, blood-pressure, non-invasive

KR

• AIRS Medical Inc. (manufacturer, Seoul, KR): 4 new FDA device listings, incl. automated radiological image processing software
• Alpha AI Co., Ltd. (manufacturer, PYEONGTAEK Gyeonggi, KR): 4 new FDA device listings, incl. thoracolumbosacral pedicle screw system
• Boditech Med Inc. (manufacturer, Chuncheon Gangwon, KR): 9 new FDA device listings, incl. antigens, all groups, streptococcus spp.
• DRTECH Corporation (manufacturer, Seongnam-si Gyeonggi, KR): 4 new FDA device listings, incl. interventional fluoroscopic x-ray system
• Edgecare Inc. (manufacturer, Yeongdeungpo-gu Seoul, KR): 4 new FDA device listings, incl. automated radiological image processing software
• Endorobotics Co., Ltd. (manufacturer, Seoul, KR): 3 new FDA device listings, incl. colonoscope and accessories, flexible/rigid
• Hi Medical Co., Ltd. (foreign exporter, Seoul, KR): 4 new FDA device listings, incl. agent, polishing, abrasive, oral cavity
• Hironic Co., Ltd. (manufacturer, Yongin-Si Gyeonggi, KR): 2 new FDA device listings, incl. brush, dermabrasion, powered
• Hlb Life Science Co., Ltd. (manufacturer, Anseong-si, Gyeonggi-do, KR): 3 new FDA device listings, incl. low dead space piston syringe
• Hydrochem Co., Ltd (contract manufacturer, Gangeung-Si Gangwon, KR): 7 new FDA device listings, incl. generator, oxygen, portable
• Jeisys Medical Inc. (manufacturer, Seoul, KR): 2 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Kbbio Co., Ltd. (manufacturer, Seongnam Gyeonggi, KR): 3 new FDA device listings, incl. respirator, surgical
• L&K Biomed Co.,Ltd. (manufacturer, Yongin-SI Gyeonggi, KR): 7 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical
• Medexel Co., Ltd. (contract manufacturer, Anseong-si Gyeonggi, KR): 3 new FDA device listings, incl. syringe, antistick
• Mediclus Co., Ltd (manufacturer, Cheongju-si Chungbuk, KR): 6 new FDA device listings, incl. liner, cavity, calcium hydroxide
• Miracell Co.,Ltd. (manufacturer, Seongnam-si Gyeonggi, KR): 3 new FDA device listings, incl. centrifuge for preparation of cell concentrate and/or plasma concentra
• Nanoentek Inc (manufacturer, Hwaseong Gyeonggi, KR): 3 new FDA device listings, incl. radioimmunoassay, total triiodothyronine
• Nanoentek Inc (specification developer, Seoul, KR): 3 new FDA device listings, incl. counter, differential cell
• Neurophet, Inc. (manufacturer, Seoul, KR): 4 new FDA device listings, incl. system, image processing, radiological
• Osstem Implant Co., Ltd. (specification developer, Gangseo-gu Seoul, KR): 2 new FDA device listings, incl. unit, operative dental
• Osstem Implant Co.,Ltd. (manufacturer, Yeonsu-gu Incheon, KR): 11 new FDA device listings, incl. chair, dental, with operative unit
• 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
• Samsung Medison Co., Ltd. (manufacturer, Gumi-si Gyeongbuk, KR): 13 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic
• Samsung Medison Co., Ltd. (manufacturer, HONGCHEON-GUN Gangwon, KR): 13 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic
• ShenB Co Ltd (manufacturer, Seongdong-gu Seoul, KR): 5 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• Siemens Healthineers Ltd. (manufacturer, Pohang-si Gyeongbuk, KR): 7 new FDA device listings, incl. catheter, ultrasound, intravascular
• Siemens Healthineers Ltd. (specification developer, SEONGNAM-SI Gyeonggi, KR): 6 new FDA device listings, incl. biopsy needle guide kit
• Spident Co., Ltd. (manufacturer, INCHEON Gyeonggi, KR): 2 new FDA device listings, incl. resin, root canal filling
• WEERO Co., Ltd. (manufacturer, Suwon-si,Gyeonggi-do, KR): 3 new FDA device listings, incl. pad, heating, powered
• Zapalign Inc. (foreign exporter, Anyang-si Gyeonggi, KR): 20 new FDA device listings, incl. agent, tooth bonding, resin
• Zeros Co., Ltd. (manufacturer, Gimhae-si Gyeongnam, KR): 2 new FDA device listings, incl. implant, endosseous, root-form
• Zimmer Biomet Korea Ltd. (foreign exporter, Seoul, KR): 8 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or

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

LV

• Light Guide Optics International Ltd. (contract manufacturer, Livani Preilu Novads, LV): 2 new FDA device listings, incl. catheter, peripheral, atherectomy
• Lsez Sia Lauma Medical / Lauma Medical Lsez LLC (contract manufacturer, Liepaja, LV): 5 new FDA device listings, incl. splint, hand, and components

Maine

• LGC Clinical Diagnostics, Inc. (manufacturer, Cumberland Foreside, ME): 2 new FDA device listings, incl. urinalysis controls (assayed and unassayed)

Maryland

• Congruence Medical Solutions, LLC (specification developer, Baltimore, MD): 2 new FDA device listings, incl. ophthalmic syringe
• Imex, LLC (manufacturer, Fulton, MD): 10 new FDA device listings, incl. electrode, cutaneous
• Maxim Biomedical Inc. (contract manufacturer, Rockville, MD): 2 new FDA device listings, incl. visual, pregnancy hcg, prescription use

Massachusetts

• 3-D Matrix, Inc. (manufacturer, Newton, MA): 4 new FDA device listings, incl. hemostatic device for endoscopic gastrointestinal use
• Access Vascular, Inc (manufacturer, Billerica, MA): 3 new FDA device listings, incl. catheter, intravascular, therapeutic, long-term greater than 30 days
• AngioDynamics, Inc. (specification developer, Marlborough, MA): 3 new FDA device listings, incl. system, ablation, microwave and accessories
• Anika Therapeutics, Inc. (manufacturer, Bedford, MA): 2 new FDA device listings, incl. absorbable synthetic wound dressing
• Anumana Inc. (manufacturer, Cambridge, MA): 2 new FDA device listings, incl. cardiac amyloidosis machine learning-based notification software
• Beacon Biosignals, Inc. (manufacturer, Boston, MA): 3 new FDA device listings, incl. standard polysomnograph with electroencephalograph
• Bicon, LLC (specification developer, Boston, MA): 2 new FDA device listings, incl. drill, dental, intraoral
• Boston Scientific Corp., Marina Bay Cust. Fulfillment Center (manufacturer, Quincy, MA): 6 new FDA device listings, incl. unit, electrosurgical, endoscopic (with or without accessories)
• Boston Scientific Corporation (specification developer, Marlborough, MA): 9 new FDA device listings, incl. ureteroscope and accessories, flexible/rigid
• Butterfly Network, Inc. (specification developer, Burlington, MA): 4 new FDA device listings, incl. transducer, ultrasonic, diagnostic
• Comforback Inc (specification developer, Auburndale, MA): 4 new FDA device listings, incl. orthosis, cervical
• Depuy Orthopaedics, Inc. (manufacturer, Raynham, MA): 4 new FDA device listings, incl. prosthesis, knee, patello/femorotibial, semi-constrained, uncemented,
• Draeger Medical Systems, Inc. (manufacturer, Andover, MA): 17 new FDA device listings, incl. continuous measurement thermometer
• E. Benson Hood Laboratories, Inc. (manufacturer, Pembroke, MA): 13 new FDA device listings, incl. bronchoscope (flexible or rigid)
• FUJIFILM Healthcare Americas Corporation (manufacturer, Lexington, MA): 9 new FDA device listings, incl. system, imaging, pulsed doppler, ultrasonic
• Isomedix Operations Inc. (contract sterilizer, Northborough, MA): 18 new FDA device listings, incl. introducer, catheter
• Karl Storz Endoscopy-America, Inc. (repackager or relabeler, Auburn, MA): 14 new FDA device listings, incl. hysteroscope (and accessories)
• Kaz USA, Inc., A Helen of Troy Company (specification developer, Marlborough, MA): 4 new FDA device listings, incl. clinical electronic thermometer
• LGC Clinical Diagnostics, Inc. (manufacturer, Milford, MA): 2 new FDA device listings, incl. equipment, laboratory, general purpose, labeled or promoted for a spec
• Menicon America, Inc. (repackager or relabeler, North Billerica, MA): 2 new FDA device listings, incl. lenses, soft contact, daily wear
• Millstone Medical Outsourcing LLC. (contract manufacturer, Fall River, MA): 24 new FDA device listings, incl. peripheral blood processing device for wound management
• Myriad Fiber Imaging Technologies, Inc. (contract manufacturer, Dudley, MA): 2 new FDA device listings, incl. insufflator, laparoscopic
• Nanoentek America, Inc (other, North Waltham, MA): 3 new FDA device listings, incl. radioimmunoassay, total triiodothyronine
• NanoHive Medical LLC (manufacturer, Woburn, MA): 3 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical
• Normatec Industries, LP (specification developer, Watertown, MA): 2 new FDA device listings, incl. pad, heating, powered
• Pascall Systems Inc (manufacturer, Cambridge, MA): 4 new FDA device listings, incl. reduced- montage standard electroencephalograph
• Performance Fibers OEM LLC (contract manufacturer, Mansfield, MA): 58 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene
• Philips North America LLC (other, Cambridge, MA): 62 new FDA device listings, incl. monitor, cardiac (incl. cardiotachometer & rate alarm)
• Primo Medical Group, INC (contract manufacturer, Stoughton, MA): 2 new FDA device listings, incl. fastener, fixation, nondegradable, soft tissue
• Siemens Healthcare Diagnostics Inc. (manufacturer, E Walpole, MA): 5 new FDA device listings, incl. test, prostate specific antigen, free, (noncomplexed) to distinguish p
• Spectrawave, Inc. (manufacturer, Bedford, MA): 17 new FDA device listings, incl. system, image processing, radiological
• Tecomet Inc. (contract manufacturer, Wilmington, MA): 3 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, cemented

Michigan

• Biopro, Inc. (contract manufacturer, Port Huron, MI): 11 new FDA device listings, incl. system, skin closure
• Greystone Medical, LLC (specification developer, Waterford, MI): 6 new FDA device listings, incl. needle, hypodermic, single lumen
• Indica-Mcs LLC (contract manufacturer, Fowlerville, MI): 3 new FDA device listings, incl. surgical table cushion
• J Sterling Industries LLC (contract manufacturer, Kalamazoo, MI): 4 new FDA device listings, incl. holder, needle; orthopedic
• Materialise USA, LLC. (manufacturer, Plymouth, MI): 3 new FDA device listings, incl. shoulder arthroplasty implantation system
• MC3, Inc. (specification developer, Dexter, MI): 4 new FDA device listings, incl. extracorporeal system for long-term respiratory / cardiopulmonary fail
• Moebius Precision Corp (contract manufacturer, Lansing, MI): 4 new FDA device listings, incl. fastener, fixation, nondegradable, soft tissue
• Packaging Compliance Medical, LLC (contract manufacturer, Kentwood, MI): 10 new FDA device listings, incl. guide, surgical, instrument
• Pioneer Surgical Technology, Inc. (contract manufacturer, Marquette, MI): 9 new FDA device listings, incl. cerclage, fixation
• Precision Edge Surgical Products Company (contract manufacturer, Sault Sainte Marie, MI): 3 new FDA device listings, incl. orthopedic stereotaxic instrument
• Safe N Simple LLC (specification developer, Clarkston, MI): 4 new FDA device listings, incl. dressing, wound, drug
• SHOULDER INNOVATIONS, Inc (specification developer, Grand Rapids, MI): 7 new FDA device listings, incl. prosthesis, shoulder, non-constrained, metal/polymer cemented
• SunMed Group Holdings, LLC (specification developer, Grand Rapids, MI): 9 new FDA device listings, incl. blood pressure cuff
• Sws-Trimac, Inc. (contract manufacturer, Saginaw, MI): 2 new FDA device listings, incl. table and attachments, operating-room

Minnesota

• Acist Medical Systems, Inc. (manufacturer, Eden Prairie, MN): 3 new FDA device listings, incl. injector and syringe, angiographic
• Benchmark Electronics, Inc. (contract manufacturer, Rochester, MN): 4 new FDA device listings, incl. unit, operative dental
• Boston Scientific Corporation (manufacturer, Saint Paul, MN): 24 new FDA device listings, incl. powered laser surgical instrument
• Boston Scientific Corporation (specification developer, Maple Grove, MN): 8 new FDA device listings, incl. catheter, continuous flush
• COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen (contract manufacturer, Eden Prairie, MN): 3 new FDA device listings, incl. bone grafting material, animal source
• EarGear LLC (specification developer, Eden Prairie, MN): 4 new FDA device listings, incl. prosthesis, adhesive, external
• EPIC MedTec OEM Catheter & Wire LLC (contract manufacturer, Plymouth, MN): 14 new FDA device listings, incl. introducer, catheter
• Fiagon Na LLC (manufacturer, Saint Paul, MN): 3 new FDA device listings, incl. balloon, nasal airway
• GN Hearing Care Corporation (other, Shakopee, MN): 2 new FDA device listings, incl. self-fitting air-conduction hearing aid, over the counter
• Gt Metabolic Solutions, Inc. (manufacturer, Saint Michael, MN): 2 new FDA device listings, incl. magnetic compression anastomosis system
• I-Tek Medical, Inc. (contract manufacturer, White Bear Lake, MN): 2 new FDA device listings, incl. cannula, surgical, general & plastic surgery
• Isomedix Operations, Inc. (contract sterilizer, Minneapolis, MN): 12 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
• MedSource Labs, LLC (manufacturer, Chanhassen, MN): 4 new FDA device listings, incl. catheter, intravascular, therapeutic, short-term less than 30 days
• Patterson Dental Supply, Inc. (repackager or relabeler, St. Paul, MN): 5 new FDA device listings, incl. resin, root canal filling
• Piraeus Medical, Inc. (manufacturer, Maple Grove, MN): 4 new FDA device listings, incl. wire, guide, catheter
• Rms Co. (contract manufacturer, Minneapolis, MN): 9 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
• St. Jude Medical, Atrial Fibrillation Division, Inc. (manufacturer, Saint Paul, MN): 3 new FDA device listings, incl. computer, diagnostic, programmable
• St. Jude Medical, Cardiology Division, Inc. (manufacturer, Plymouth, MN): 4 new FDA device listings, incl. computer, diagnostic, programmable

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
• Millstone Medical Outsourcing LLC (contract manufacturer, Olive Branch, MS): 272 new FDA device listings, incl. screw, fixation, bone

Missouri

• Biomerieux, Inc. (manufacturer, Hazelwood, MO): 11 new FDA device listings, incl. susceptibility test cards, antimicrobial
• Midwest Sterilization Corp. (contract sterilizer, Jackson, MO): 20 new FDA device listings, incl. stimulator, spinal-cord, implanted (pain relief)
• Surgical Instrument Manufacturers, LLC (contract manufacturer, Fenton, MO): 13 new FDA device listings, incl. sacroiliac joint fixation

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
• Medline Industries, LP - Mexicali (MXC) (manufacturer, Mexicali Baja California, MX): 4 new FDA device listings, incl. tubes, vials, systems, serum separators, blood collection
• Tutamen De Mexico, LLC (manufacturer, Tijuana Baja California, MX): 4 new FDA device listings, incl. immunoglobulin g (igg) infusion system

Nevada

• Eiger Diagnostics, Inc. (manufacturer, Las Vegas, NV): 3 new FDA device listings, incl. device, general purpose, microbiology, diagnostic
• Medicreations LLC (repackager or relabeler, Las Vegas, NV): 3 new FDA device listings, incl. powered laser surgical instrument
• Merits Health Products, Inc. (contract manufacturer, Las Vegas, NV): 18 new FDA device listings, incl. wheelchair, powered
• Paragon Implant Company, LLC (manufacturer, Las Vegas, NV): 2 new FDA device listings, incl. implant, endosseous, root-form
• Restore Robotics Repairs LLC (remanufacturer, Henderson, NV): 2 new FDA device listings, incl. system, surgical, computer controlled instrument, remanufactured

New Hampshire

• A.M. Surgical, Inc. (specification developer, Nashua, NH): 4 new FDA device listings, incl. tray, surgical, instrument
• Deka Research & Development Corp. (specification developer, Manchester, NH): 4 new FDA device listings, incl. controller, infusion, intravascular, electronic
• EPIC MedTec OEM LLC (contract manufacturer, Jaffrey, NH): 2 new FDA device listings, incl. tubes, gastrointestinal (and accessories)
• Millyard Advanced Medical Products LLC (manufacturer, Manchester, NH): 3 new FDA device listings, incl. insulin pump secondary display
• Revive Regenerative Inc. (other, Nashua, NH): 4 new FDA device listings, incl. massager, vacuum, radio frequency induced heat
• Symmetry Medical, Inc. - Manchester (contract manufacturer, Manchester, NH): 4 new FDA device listings, incl. orthopedic stereotaxic instrument
• Venus Concept Inc. (manufacturer, Windham, NH): 7 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories

New Jersey

• Church & Dwight Co., Inc. (other, Princeton, NJ): 2 new FDA device listings, incl. condom
• Diagnostica Stago, Inc. (other, Parsippany, NJ): 6 new FDA device listings, incl. test, time, partial thromboplastin
• DRG International, Inc. (repackager or relabeler, Springfield, NJ): 13 new FDA device listings, incl. prostate-specific antigen (psa) for management of prostate cancers
• Dsv Contract Logistics LLC (repackager or relabeler, Port Reading, NJ): 18 new FDA device listings, incl. orthosis, foot drop
• Ethicon, Inc. (specification developer, Raritan, NJ): 3 new FDA device listings, incl. suture, absorbable, synthetic, polyglycolic acid
• Ethos Biosciences, INC. (contract manufacturer, Logan Township, NJ): 4 new FDA device listings, incl. van gieson's stain
• Euroimmun Us Inc. (other, Mountain Lakes, NJ): 3 new FDA device listings, incl. extractable antinuclear antibody, antigen and control
• Extremity Medical, LLC (specification developer, Parsippany, NJ): 2 new FDA device listings, incl. instrument, surgical, orthopedic, ac-powered motor and accessory/attac
• FUJIFILM Healthcare Americas Corporation (repackager or relabeler, Edison, NJ): 9 new FDA device listings, incl. single (specified) analyte controls (assayed and unassayed)
• Howmedica Osteonics Corp (manufacturer, Mahwah, NJ): 11 new FDA device listings, incl. prosthesis, knee, patello/femorotibial, semi-constrained, uncemented,
• Isomedix Operations Inc. (contract sterilizer, S Plainfield, NJ): 16 new FDA device listings, incl. sealant, microbial
• Isomedix Operations Inc. (contract sterilizer, Whippany, NJ): 26 new FDA device listings, incl. orthopedic stereotaxic instrument
• Medin Technologies, Inc. (contract manufacturer, Totowa, NJ): 20 new FDA device listings, incl. screw, fixation, bone
• Menasha Packaging Company ,LLC (repackager or relabeler, Edison, NJ): 3 new FDA device listings, incl. condom, synthetic
• MINDRAY DS USA, Inc. (contract manufacturer, Mahwah, NJ): 62 new FDA device listings, incl. continuous, minimal ventilatory support, facility use ventilator
• Mouthwatch, Inc. (specification developer, Metuchen, NJ): 2 new FDA device listings, incl. scraper, tongue
• Roche Molecular Systems, Inc. (manufacturer, Branchburg, NJ): 4 new FDA device listings, incl. vaginitis and bacterial vaginosis nucleic acid detection system
• Topcon Healthcare, Inc. (manufacturer, Oakland, NJ): 9 new FDA device listings, incl. refractometer, ophthalmic
• UPS Supply Chain Solutions, Inc. (repackager or relabeler, Pedricktown, NJ): 4 new FDA device listings, incl. enzyme linked immunoabsorbent assay, mumps virus
• Valmar Surgical Supplies, Inc. (repackager or relabeler, Lakewood, NJ): 8 new FDA device listings, incl. bedding, disposable, medical
• Vision Rx Lab America LLC (remanufacturer, Cranford, NJ): 4 new FDA device listings, incl. spectacle, magnifying
• Zeus Scientific LLC (manufacturer, Branchburg, NJ): 7 new FDA device listings, incl. extractable antinuclear antibody, antigen and control

New Mexico

• Nypro Healthcare Baja Inc. (Albuquerque) (contract manufacturer, Albuquerque, NM): 4 new FDA device listings, incl. staple, implantable
• Sterigenics U.S., LLC (contract sterilizer, Santa Teresa, NM): 17 new FDA device listings, incl. apron, leaded

New York

• Alc Enterprises Inc (specification developer, Brooklyn, NY): 4 new FDA device listings, incl. over-the-counter powered light based laser for acne
• American Diagnostic Corp. (repackager or relabeler, Hauppauge, NY): 3 new FDA device listings, incl. continuous measurement thermometer
• Angiodynamics, Inc (manufacturer, Glens Falls, NY): 3 new FDA device listings, incl. system, ablation, microwave and accessories
• Angiodynamics, Inc. (manufacturer, Queensbury, NY): 3 new FDA device listings, incl. system, ablation, microwave and accessories
• Central Assn. For The Blind (repackager or relabeler, Utica, NY): 4 new FDA device listings, incl. medical glove, specialty
• Cogentix Medical, Inc. (manufacturer, Orangeburg, NY): 2 new FDA device listings, incl. cystoscope and accessories, flexible/rigid
• Conmed Corporation (other, Utica, NY): 3 new FDA device listings, incl. fastener, fixation, nondegradable, soft tissue
• Dukal LLC (specification developer, Ronkonkoma, NY): 3 new FDA device listings, incl. wound dressing with animal-derived material(s)
• Endure Industries, Inc. (specification developer, Homer, NY): 14 new FDA device listings, incl. cannula, nasal, oxygen
• Harmony Health Tech Inc (repackager or relabeler, Brooklyn, NY): 3 new FDA device listings, incl. massager, powered inflatable tube

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