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- Page 5

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

Every DeviceEstablishmentPulse record report, 200 per page, grouped by state. Records 801 to 1,000: Isomedix Operations Inc. (contract sterilizer, Chester, NY): 3 new FDA device listings, incl. dressing, wound, drug to Coba Biomedical PTY (Ltd) (contract manufacturer, Bloemfontein Free State, ZA): 27 new FDA device listings, incl. hook, ophthalmic. 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](/hub/deviceestablishmentpulse/records/4) 5

## New York

- [Isomedix Operations Inc. (contract sterilizer, Chester, NY): 3 new FDA device listings, incl. dressing, wound, drug](/report/deviceestablishmentpulse/isomedix-operations-inc-chester-ny--fdaest-1319660-2026-09-28)
- [Metropolis International, LLC (repackager or relabeler, Long Island City, NY): 2 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/metropolis-international-llc-long-island-city-ny--fdaest-3005877899-2026-09-10)
- [Microstructure Imaging, Inc (specification developer, Brooklyn, NY): 2 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/microstructure-imaging-inc-brooklyn-ny--fdaest-3038191646-2026-10-06)
- [Pathwai, Inc (manufacturer, New York, NY): 6 new FDA device listings, incl. pulmonary hypertension machine learning-based notification software](/report/deviceestablishmentpulse/pathwai-inc-new-york-ny--fdaest-3046433998-2026-06-12)
- [Praxis Powder Technology, Inc. (contract manufacturer, Queensbury, NY): 5 new FDA device listings, incl. cerclage, fixation](/report/deviceestablishmentpulse/praxis-powder-technology-inc-queensbury-ny--fdaest-3007304202-2026-06-09)
- [Premium Plus Dental Supplies Inc (other, Brooklyn, NY): 12 new FDA device listings, incl. material, impression](/report/deviceestablishmentpulse/premium-plus-dental-supplies-inc-brooklyn-ny--fdaest-3004425647-2026-09-25)
- [Radformation, Inc. (manufacturer, New York, NY): 3 new FDA device listings, incl. radiological image processing software for radiation therapy](/report/deviceestablishmentpulse/radformation-inc-new-york-ny--fdaest-3013410552-2026-09-10)
- [Safetec Of America, Inc. (manufacturer, Buffalo, NY): 6 new FDA device listings, incl. cement, stomal appliance, ostomy](/report/deviceestablishmentpulse/safetec-of-america-inc-buffalo-ny--fdaest-1319744-2026-09-29)
- [Secured Ortho Manufacturing Of America, LLC (specification developer, Deer Park, NY): 2 new FDA device listings, incl. sleeve, limb, compressible](/report/deviceestablishmentpulse/secured-ortho-manufacturing-of-america-llc-deer-park-ny--fdaest-3014658541-2026-09-03)
- [Siemens Healthcare Diagnostics Inc. (specification developer, Tarrytown, NY): 9 new FDA device listings, incl. colorimetry, acetaminophen](/report/deviceestablishmentpulse/siemens-healthcare-diagnostics-inc-tarrytown-ny--fdaest-2432235-2026-08-27)
- [Skil-Care Corp. (contract manufacturer, New Rochelle, NY): 4 new FDA device listings, incl. adaptor, dressing](/report/deviceestablishmentpulse/skil-care-corp-new-rochelle-ny--fdaest-2431497-2026-07-15)
- [Sterigenics U.S., LLC (contract sterilizer, Queensbury, NY): 68 new FDA device listings, incl. electrode, cortical](/report/deviceestablishmentpulse/sterigenics-u-s-llc-queensbury-ny--fdaest-1319639-2026-09-15)
- [Sxwell USA LLC (specification developer, New York, NY): 4 new FDA device listings, incl. lubricant, personal](/report/deviceestablishmentpulse/sxwell-usa-llc-new-york-ny--fdaest-3013388459-2026-09-14)

## North Carolina

- [Acme United Corp. (repackager or relabeler, Rocky Mount, NC): 2 new FDA device listings, incl. dressing, wound, occlusive](/report/deviceestablishmentpulse/acme-united-corp-rocky-mount-nc--fdaest-1025972-2026-08-16)
- [Emage Medical, LLC (other, Charlotte, NC): 5 new FDA device listings, incl. massager, therapeutic, electric](/report/deviceestablishmentpulse/emage-medical-llc-charlotte-nc--fdaest-3007645866-2026-07-16)
- [Holger Bumueller LLC (contract manufacturer, Rutherfordton, NC): 3 new FDA device listings, incl. dilator, lachrymal](/report/deviceestablishmentpulse/holger-bumueller-llc-rutherfordton-nc--fdaest-3007840839-2026-07-06)
- [Konica Minolta Healthcare Americas, Inc (manufacturer, Garner, NC): 2 new FDA device listings, incl. solid state x-ray imager (flat panel/digital imager)](/report/deviceestablishmentpulse/konica-minolta-healthcare-americas-inc-garner-nc--fdaest-1064396-2026-09-03)
- [Lightning X Products, Inc (manufacturer, Charlotte, NC): 32 new FDA device listings, incl. airway, oropharyngeal, anesthesiology](/report/deviceestablishmentpulse/lightning-x-products-inc-charlotte-nc--fdaest-3012311599-2026-09-11)
- [Mdd Options, LLC (other, New Hill, NC): 3 new FDA device listings, incl. spinner, slide, automated](/report/deviceestablishmentpulse/mdd-options-llc-new-hill-nc--fdaest-3040937533-2026-10-15)
- [Medical Action Industries, Inc. 306 (manufacturer, Arden, NC): 4 new FDA device listings, incl. medical glove, specialty](/report/deviceestablishmentpulse/medical-action-industries-inc-306-arden-nc--fdaest-1030451-2026-09-16)
- [Pulmera Inc. (specification developer, Charlotte, NC): 2 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/pulmera-inc-charlotte-nc--fdaest-3049422862-2026-09-08)
- [restor3d, inc. (manufacturer, Durham, NC): 4 new FDA device listings, incl. shoulder prosthesis, reverse configuration](/report/deviceestablishmentpulse/restor3d-inc-durham-nc--fdaest-3014833750-2026-07-21)
- [Salvin Dental Specialties, LLC (repackager or relabeler, Charlotte, NC): 3 new FDA device listings, incl. bone grafting material, animal source](/report/deviceestablishmentpulse/salvin-dental-specialties-llc-charlotte-nc--fdaest-1066741-2026-09-02)
- [Sterigenics U.S., LLC (contract sterilizer, Charlotte, NC): 15 new FDA device listings, incl. radioimmunoassay, thyroid-stimulating hormone](/report/deviceestablishmentpulse/sterigenics-u-s-llc-charlotte-nc--fdaest-1061124-2026-06-04)
- [Sterigenics US LLC (contract sterilizer, Charlotte, NC): 16 new FDA device listings, incl. rod, fixation, intramedullary and accessories](/report/deviceestablishmentpulse/sterigenics-us-llc-charlotte-nc--fdaest-1058584-2026-07-10)
- [Structure Medical, LLC. (contract manufacturer, Mooresville, NC): 7 new FDA device listings, incl. appliance, fixation, spinal intervertebral body](/report/deviceestablishmentpulse/structure-medical-llc-mooresville-nc--fdaest-3007993775-2026-09-15)
- [Teleflex Medical LLC (specification developer, Morrisville, NC): 4 new FDA device listings, incl. suture, surgical, absorbable, polydioxanone](/report/deviceestablishmentpulse/teleflex-medical-llc-morrisville-nc--fdaest-3011137372-2026-07-31)
- [Ulthera Inc (specification developer, Raleigh, NC): 2 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic](/report/deviceestablishmentpulse/ulthera-inc-raleigh-nc--fdaest-1012187-2026-09-23)

## Ohio

- [Aps Materials, Inc. (contract manufacturer, Dayton, OH): 12 new FDA device listings, incl. prosthesis, shoulder, semi-constrained, metal/polymer cemented](/report/deviceestablishmentpulse/aps-materials-inc-dayton-oh--fdaest-1529009-2026-07-20)
- [Guardian Medical USA, Inc (contract manufacturer, Swanton, OH): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar](/report/deviceestablishmentpulse/guardian-medical-usa-inc-swanton-oh--fdaest-3016261131-2026-06-24)
- [Hammill Mfg. Co. (contract manufacturer, Maumee, OH): 4 new FDA device listings, incl. appliance, fixation, spinal intervertebral body](/report/deviceestablishmentpulse/hammill-mfg-co-maumee-oh--fdaest-1530390-2026-08-17)
- [Health Care Logistics, Inc. (repackager or relabeler, Urbancrest, OH): 5 new FDA device listings, incl. set, administration, intravascular](/report/deviceestablishmentpulse/health-care-logistics-inc-urbancrest-oh--fdaest-1530671-2026-07-02)
- [Huneo, LLC (manufacturer, Willoughby Hills, OH): 3 new FDA device listings, incl. automatic event detection software for polysomnograph with electroence](/report/deviceestablishmentpulse/huneo-llc-willoughby-hills-oh--fdaest-3047516694-2026-07-30)
- [Neoconcepts LLC (other, Lewis Center, OH): 3 new FDA device listings, incl. low power electrosurgical devices for skin lesion destruction](/report/deviceestablishmentpulse/neoconcepts-llc-lewis-center-oh--fdaest-3015227849-2026-08-12)
- [Sterigenics US, LLC (contract sterilizer, Lewis Center, OH): 38 new FDA device listings, incl. injector and syringe, angiographic](/report/deviceestablishmentpulse/sterigenics-us-llc-lewis-center-oh--fdaest-1526534-2026-08-26)
- [True Indicating LLC (manufacturer, Toledo, OH): 2 new FDA device listings, incl. biological sterilization indicator with indirect growth detection](/report/deviceestablishmentpulse/true-indicating-llc-toledo-oh--fdaest-3017524825-2026-09-21)

## Oklahoma

- [Smith & Nephew Inc. (manufacturer, Oklahoma City, OK): 3 new FDA device listings, incl. intra-articular orthopedic stereotaxic navigation instrument](/report/deviceestablishmentpulse/smith-and-nephew-inc-oklahoma-city-ok--fdaest-1643264-2026-09-14)

## Oregon

- [Orchid Orthopedic Solutions Oregon, Inc. (contract manufacturer, Oregon City, OR): 3 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol](/report/deviceestablishmentpulse/orchid-orthopedic-solutions-oregon-inc-oregon-city-or--fdaest-3009848551-2026-10-05)
- [Ortho-Med, Inc. (repackager or relabeler, Tigard, OR): 6 new FDA device listings, incl. tray, surgical, instrument](/report/deviceestablishmentpulse/ortho-med-inc-tigard-or--fdaest-3019455-2026-07-14)

## Pennsylvania

- [Aesculap, Inc. (other, Center Valley, PA): 2 new FDA device listings, incl. shunt, central nervous system and components](/report/deviceestablishmentpulse/aesculap-inc-center-valley-pa--fdaest-2916714-2026-10-07)
- [Alta Smiles, LLC (manufacturer, Fort Washington, PA): 13 new FDA device listings, incl. instrument, ligature tucking, orthodontic](/report/deviceestablishmentpulse/alta-smiles-llc-fort-washington-pa--fdaest-3017138012-2026-08-24)
- [Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components (contract manufacturer, Huntingdon Valley, PA): 20 new FDA device listings, incl. thoracolumbosacral pedicle screw system](/report/deviceestablishmentpulse/arch-medical-solutions-philadelphia-llc-dba-jade-precision-huntingdon-valley-pa--fdaest-3006791286-2026-08-20)
- [B. Braun Medical Inc. (other, Allentown, PA): 2 new FDA device listings, incl. system, irrigation, urological](/report/deviceestablishmentpulse/b-braun-medical-inc-allentown-pa--fdaest-3013764800-2026-09-14)
- [Bechtel Medical Inc (manufacturer, Phoenixville, PA): 2 new FDA device listings, incl. dressing, wound, occlusive](/report/deviceestablishmentpulse/bechtel-medical-inc-phoenixville-pa--fdaest-3043172326-2026-09-13)
- [Centinel Spine, LLC (specification developer, West Chester, PA): 2 new FDA device listings, incl. manual instruments designed for use with total disc replacement device](/report/deviceestablishmentpulse/centinel-spine-llc-west-chester-pa--fdaest-3007494564-2026-10-06)
- [Choicemmed America Corporation (repackager or relabeler, Bristol, PA): 3 new FDA device listings, incl. bottle, collection, vacuum](/report/deviceestablishmentpulse/choicemmed-america-corporation-bristol-pa--fdaest-3008507279-2026-05-06)
- [Fruh Packaging Inc. (contract manufacturer, Exton, PA): 2 new FDA device listings, incl. plate, fixation, bone](/report/deviceestablishmentpulse/fruh-packaging-inc-exton-pa--fdaest-3030714745-2026-10-14)
- [Globus Medical, Inc. (manufacturer, Audubon, PA): 16 new FDA device listings, incl. thoracolumbosacral pedicle screw system](/report/deviceestablishmentpulse/globus-medical-inc-audubon-pa--fdaest-3004142400-2026-08-05)
- [HR PHARMACEUTICALS, INC d/b/a HR HealthCare (manufacturer, York, PA): 4 new FDA device listings, incl. collector, urine, powered, non indwelling catheter](/report/deviceestablishmentpulse/hr-pharmaceuticals-inc-d-b-a-hr-healthcare-york-pa--fdaest-3008502431-2026-08-21)
- [NuVasive Specialized Orthopedics, Inc. (manufacturer, Audubon, PA): 2 new FDA device listings, incl. rod, fixation, intramedullary and accessories](/report/deviceestablishmentpulse/nuvasive-specialized-orthopedics-inc-audubon-pa--fdaest-3006179046-2026-09-22)
- [Philips Ultrasound LLC (contract manufacturer, Reedsville, PA): 32 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/philips-ultrasound-llc-reedsville-pa--fdaest-2518586-2026-09-30)
- [Septodont, Inc (specification developer, Lancaster, PA): 2 new FDA device listings, incl. device, electrical dental anesthesia](/report/deviceestablishmentpulse/septodont-inc-lancaster-pa--fdaest-3008242564-2026-08-19)
- [Sound Technology Inc. (manufacturer, State College, PA): 4 new FDA device listings, incl. automated radiological image processing software](/report/deviceestablishmentpulse/sound-technology-inc-state-college-pa--fdaest-2532090-2026-09-18)
- [Synthes (USA) Products LLC (specification developer, West Chester, PA): 5 new FDA device listings, incl. plate, cranioplasty, preformed, non-alterable](/report/deviceestablishmentpulse/synthes-usa-products-llc-west-chester-pa--fdaest-3008812560-2026-06-17)
- [Tela Bio, Inc. (manufacturer, Malvern, PA): 2 new FDA device listings, incl. mesh, surgical, polymeric](/report/deviceestablishmentpulse/tela-bio-inc-malvern-pa--fdaest-3010513348-2026-10-07)
- [Trend Medical, LLC (specification developer, Bethlehem, PA): 4 new FDA device listings, incl. splint, hand, and components](/report/deviceestablishmentpulse/trend-medical-llc-bethlehem-pa--fdaest-3012453117-2026-09-15)
- [X-Nav Technologies, LLC. (manufacturer, Lansdale, PA): 2 new FDA device listings, incl. dental navigation system](/report/deviceestablishmentpulse/x-nav-technologies-llc-lansdale-pa--fdaest-3011764595-2026-09-21)

## PH

- [Philipcare Medical Manufacturing Inc. (contract manufacturer, Lipa Batangas, PH): 2 new FDA device listings, incl. mattress, flotation therapy, non-powered](/report/deviceestablishmentpulse/philipcare-medical-manufacturing-inc-lipa-batangas-ph--fdaest-3033506545-2026-09-08)

## PK

- [Acheron Instruments (Pvt.) Ltd. (manufacturer, LAHORE Punjab, PK): 134 new FDA device listings, incl. laryngoscope, non-rigid](/report/deviceestablishmentpulse/acheron-instruments-pvt-ltd-lahore-punjab-pk--fdaest-3011600579-2026-08-07)
- [Acme Commercial Ways Ltd. (manufacturer, Sialkot Punjab, PK): 4 new FDA device listings, incl. syringe, cartridge](/report/deviceestablishmentpulse/acme-commercial-ways-ltd-sialkot-punjab-pk--fdaest-3008797953-2026-09-15)
- [Densol International (Private) Limited (manufacturer, Sialkot Punjab, PK): 35 new FDA device listings, incl. mirror, mouth](/report/deviceestablishmentpulse/densol-international-private-limited-sialkot-punjab-pk--fdaest-3043239665-2026-08-20)
- [Garana Industries Private Limited (contract manufacturer, SIALKOT Punjab, PK): 4 new FDA device listings, incl. instrument, cast application/removal, manual](/report/deviceestablishmentpulse/garana-industries-private-limited-sialkot-punjab-pk--fdaest-3003759558-2026-08-17)
- [Hexamed Pvt Ltd (contract manufacturer, Sialkot Punjab, PK): 59 new FDA device listings, incl. scissors, nasal](/report/deviceestablishmentpulse/hexamed-pvt-ltd-sialkot-punjab-pk--fdaest-3032747418-2026-08-07)
- [Madhi Corporation (manufacturer, Sialkot Punjab, PK): 3 new FDA device listings, incl. curette, surgical, general use](/report/deviceestablishmentpulse/madhi-corporation-sialkot-punjab-pk--fdaest-3005194291-2026-08-04)
- [Medcave Private Limited (manufacturer, Sialkot Punjab, PK): 100 new FDA device listings, incl. wrench](/report/deviceestablishmentpulse/medcave-private-limited-sialkot-punjab-pk--fdaest-3021666757-2026-09-24)
- [Myka Sons & Co (manufacturer, Sialkot Punjab, PK): 2 new FDA device listings, incl. mirror, mouth](/report/deviceestablishmentpulse/myka-sons-and-co-sialkot-punjab-pk--fdaest-3006004547-2026-09-17)
- [Surgicon Pvt Ltd (contract manufacturer, Sialkot Punjab, PK): 9 new FDA device listings, incl. hook, microsurgical ear](/report/deviceestablishmentpulse/surgicon-pvt-ltd-sialkot-punjab-pk--fdaest-3007597038-2026-09-18)

## Puerto Rico

- [Bard Shannon Limited (contract manufacturer, Humacao, PR): 3 new FDA device listings, incl. mesh, surgical, polymeric](/report/deviceestablishmentpulse/bard-shannon-limited-humacao-pr--fdaest-3005636544-2026-10-14)
- [Ethicon, LLC (manufacturer, Guaynabo, PR): 3 new FDA device listings, incl. suture, surgical, absorbable, polydioxanone](/report/deviceestablishmentpulse/ethicon-llc-guaynabo-pr--fdaest-3007791599-2026-06-02)
- [Medtronic Puerto Rico Operations Co., Humacao (manufacturer, Humacao, PR): 3 new FDA device listings, incl. appliance, fixation, spinal interlaminal](/report/deviceestablishmentpulse/medtronic-puerto-rico-operations-co-humacao-humacao-pr--fdaest-2647346-2026-05-05)
- [Steris Isomedix Puerto Rico, Inc. (contract sterilizer, Alts De Cerro Gordo 3&4, PR): 3 new FDA device listings, incl. thoracolumbosacral pedicle screw system](/report/deviceestablishmentpulse/steris-isomedix-puerto-rico-inc-alts-de-cerro-gordo-3-and-4-pr--fdaest-2648623-2026-05-06)
- [Stryker Puerto Rico, LLC. (contract manufacturer, Arroyo, PR): 4 new FDA device listings, incl. nasopharyngoscope (flexible or rigid)](/report/deviceestablishmentpulse/stryker-puerto-rico-llc-arroyo-pr--fdaest-2648666-2026-06-22)

## Rhode Island

- [Boston Scientific Corporation (manufacturer, Coventry, RI): 10 new FDA device listings, incl. unit, electrosurgical, endoscopic (with or without accessories)](/report/deviceestablishmentpulse/boston-scientific-corporation-coventry-ri--fdaest-1000121056-2026-10-16)
- [Davol Inc., Sub. C.R. Bard, Inc. (specification developer, Warwick, RI): 3 new FDA device listings, incl. mesh, surgical, polymeric](/report/deviceestablishmentpulse/davol-inc-sub-c-r-bard-inc-warwick-ri--fdaest-1213643-2026-10-14)
- [Emblation Inc. (other, Lincoln, RI): 3 new FDA device listings, incl. system, ablation, microwave and accessories](/report/deviceestablishmentpulse/emblation-inc-lincoln-ri--fdaest-3015152398-2026-06-08)

## SG

- [Beyonics International PTE. Ltd. (contract manufacturer, SINGAPORE North West, SG): 5 new FDA device listings, incl. stimulator, nerve](/report/deviceestablishmentpulse/beyonics-international-pte-ltd-singapore-north-west-sg--fdaest-3003080184-2026-08-31)
- [Cmt Health PTE. Ltd. (specification developer, Singapore, SG): 9 new FDA device listings, incl. needle, hypodermic, single lumen](/report/deviceestablishmentpulse/cmt-health-pte-ltd-singapore-sg--fdaest-3036722184-2026-08-03)
- [Jabil Circuit (Singapore) Pte Ltd (contract manufacturer, Singapore Central Singapore, SG): 4 new FDA device listings, incl. reduced- montage standard electroencephalograph](/report/deviceestablishmentpulse/jabil-circuit-singapore-pte-ltd-singapore-central-singapore-sg--fdaest-3009247326-2026-09-25)
- [Steris Tomoe Singapore PTE Ltd (contract sterilizer, Singapore South West, SG): 10 new FDA device listings, incl. ureteroscope and accessories, flexible/rigid](/report/deviceestablishmentpulse/steris-tomoe-singapore-pte-ltd-singapore-south-west-sg--fdaest-3010421104-2026-09-09)
- [Uan Prime PTE. Ltd. (foreign exporter, singapora, SG): 40 new FDA device listings, incl. cushion, wheelchair](/report/deviceestablishmentpulse/uan-prime-pte-ltd-singapora-sg--fdaest-3045752480-2026-07-23)

## South Carolina

- [Arthrex Manufacturing Inc. (contract manufacturer, Pendleton, SC): 7 new FDA device listings, incl. fastener, fixation, biodegradable, soft tissue](/report/deviceestablishmentpulse/arthrex-manufacturing-inc-pendleton-sc--fdaest-3015231789-2026-09-27)
- [Isomedix Operations Inc. (contract sterilizer, Spartanburg, SC): 8 new FDA device listings, incl. drills, burrs, trephines & accessories (manual)](/report/deviceestablishmentpulse/isomedix-operations-inc-spartanburg-sc--fdaest-1047843-2026-10-14)
- [North American Rescue, LLC. (manufacturer, Greer, SC): 5 new FDA device listings, incl. burn kit without drug](/report/deviceestablishmentpulse/north-american-rescue-llc-greer-sc--fdaest-3005034064-2026-07-17)

## South Dakota

- [Spartronics Watertown LLC (contract manufacturer, Watertown, SD): 6 new FDA device listings, incl. stimulator, spinal-cord, totally implanted for pain relief](/report/deviceestablishmentpulse/spartronics-watertown-llc-watertown-sd--fdaest-2133772-2026-07-30)

## Tennessee

- [Alphatec Spine, Inc. (manufacturer, Memphis, TN): 10 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/alphatec-spine-inc-memphis-tn--fdaest-3019878714-2026-07-28)
- [Daxor Corporation (manufacturer, Oak Ridge, TN): 2 new FDA device listings, incl. container, specimen, non-sterile](/report/deviceestablishmentpulse/daxor-corporation-oak-ridge-tn--fdaest-3003529145-2026-08-24)
- [Dt Medtech LLC (specification developer, McMinnville, TN): 11 new FDA device listings, incl. gauge, depth](/report/deviceestablishmentpulse/dt-medtech-llc-mcminnville-tn--fdaest-3012104767-2026-07-09)
- [Elite Medical, LLC (contract manufacturer, Bartlett, TN): 17 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical](/report/deviceestablishmentpulse/elite-medical-llc-bartlett-tn--fdaest-3009882675-2026-09-03)
- [Elite Medical, LLC (contract manufacturer, Cordova, TN): 2 new FDA device listings, incl. spinal vertebral body replacement device](/report/deviceestablishmentpulse/elite-medical-llc-cordova-tn--fdaest-3017528621-2026-09-03)
- [Engineered Medical Systems, LLC (contract manufacturer, Bartlett, TN): 29 new FDA device listings, incl. spinal vertebral body replacement device](/report/deviceestablishmentpulse/engineered-medical-systems-llc-bartlett-tn--fdaest-3009973336-2026-09-03)
- [Globus Medical, Inc. (manufacturer, Memphis, TN): 12 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, uncemented](/report/deviceestablishmentpulse/globus-medical-inc-memphis-tn--fdaest-3030412764-2026-08-05)
- [Medical Buyers Group, LLC (repackager or relabeler, Brentwood, TN): 2 new FDA device listings, incl. system, blood collection, vacuum-assisted, manual](/report/deviceestablishmentpulse/medical-buyers-group-llc-brentwood-tn--fdaest-3020502814-2026-10-18)
- [Medtronic Sofamor Danek USA, Inc. (specification developer, Memphis, TN): 5 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar](/report/deviceestablishmentpulse/medtronic-sofamor-danek-usa-inc-memphis-tn--fdaest-1030489-2026-07-27)
- [Mr. Christmas LLC (other, Memphis, TN): 5 new FDA device listings, incl. sunglasses (non-prescription including photosensitive)](/report/deviceestablishmentpulse/mr-christmas-llc-memphis-tn--fdaest-1000188284-2026-10-06)
- [Plastic Electromechanic Company Medical Device (manufacturer, Bir Mcherga Zaghouan, TN): 2 new FDA device listings, incl. spirometer, therapeutic (incentive)](/report/deviceestablishmentpulse/plastic-electromechanic-company-medical-device-bir-mcherga-zaghouan-tn--fdaest-3042888450-2026-08-19)
- [Smith & Nephew, Inc. (manufacturer, Memphis, TN): 2 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol](/report/deviceestablishmentpulse/smith-and-nephew-inc-memphis-tn--fdaest-3007366790-2026-09-14)
- [Smith & Nephew, Inc. (manufacturer, Memphis, TN): 2 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol](/report/deviceestablishmentpulse/smith-and-nephew-inc-memphis-tn--fdaest-1020279-2026-09-14)
- [Vilex LLC (manufacturer, Mcminnville, TN): 9 new FDA device listings, incl. starter, bone screw](/report/deviceestablishmentpulse/vilex-llc-mcminnville-tn--fdaest-1051526-2026-07-28)
- [Wright Medical Technology, Inc. (manufacturer, Arlington, TN): 5 new FDA device listings, incl. filler, bone void, calcium compound](/report/deviceestablishmentpulse/wright-medical-technology-inc-arlington-tn--fdaest-1043534-2026-09-28)
- [Wright Medical Technology, Inc. (specification developer, Arlington, TN): 5 new FDA device listings, incl. filler, bone void, calcium compound](/report/deviceestablishmentpulse/wright-medical-technology-inc-arlington-tn--fdaest-3010667733-2026-09-28)

## Texas

- [Eminent Spine, LLC (manufacturer, Plano, TX): 2 new FDA device listings, incl. thoracolumbosacral pedicle screw system](/report/deviceestablishmentpulse/eminent-spine-llc-plano-tx--fdaest-3007345964-2026-09-14)
- [Fx Shoulder Solutions Inc. (specification developer, Addison, TX): 4 new FDA device listings, incl. shoulder prosthesis, reverse configuration](/report/deviceestablishmentpulse/fx-shoulder-solutions-inc-addison-tx--fdaest-3014128390-2026-05-14)
- [Gramercy Extremity Orthopedics, LLC. (manufacturer, Richardson, TX): 9 new FDA device listings, incl. countersink](/report/deviceestablishmentpulse/gramercy-extremity-orthopedics-llc-richardson-tx--fdaest-3012478585-2026-06-24)
- [Healgen Scientific LLC (specification developer, Houston, TX): 3 new FDA device listings, incl. kit, direct antigen, negative control](/report/deviceestablishmentpulse/healgen-scientific-llc-houston-tx--fdaest-3009238284-2026-07-29)
- [Inspiration Medical Technology, Inc. (repackager or relabeler, Carrollton, TX): 5 new FDA device listings, incl. dressing, wound, hydrophilic](/report/deviceestablishmentpulse/inspiration-medical-technology-inc-carrollton-tx--fdaest-3012940386-2026-07-19)
- [Maestro Logistics, LLC (contract manufacturer, Austin, TX): 2 new FDA device listings, incl. washer, bolt nut](/report/deviceestablishmentpulse/maestro-logistics-llc-austin-tx--fdaest-3014129047-2026-10-16)
- [Mastercraft Dental Co. Of Texas (manufacturer, Midlothian, TX): 4 new FDA device listings, incl. chair, with casters](/report/deviceestablishmentpulse/mastercraft-dental-co-of-texas-midlothian-tx--fdaest-1625854-2026-09-11)
- [Maxter Healthcare Inc (manufacturer, Rosharon, TX): 4 new FDA device listings, incl. fentanyl and other opioid protection glove](/report/deviceestablishmentpulse/maxter-healthcare-inc-rosharon-tx--fdaest-3033715710-2026-10-05)
- [Midwest Sterilization Corp. (contract sterilizer, Laredo, TX): 13 new FDA device listings, incl. catheter, percutaneous](/report/deviceestablishmentpulse/midwest-sterilization-corp-laredo-tx--fdaest-3005012805-2026-07-21)
- [Mlife Diagnostics LLC (contract manufacturer, Marshall, TX): 11 new FDA device listings, incl. test, methamphetamine, over the counter](/report/deviceestablishmentpulse/mlife-diagnostics-llc-marshall-tx--fdaest-3017060097-2026-07-17)
- [Rapid Medical Inc. (other, Southlake, TX): 4 new FDA device listings, incl. catheter, thrombus retriever](/report/deviceestablishmentpulse/rapid-medical-inc-southlake-tx--fdaest-3015531723-2026-09-20)
- [Sterigenics US LLC (contract sterilizer, Fort Worth, TX): 58 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar](/report/deviceestablishmentpulse/sterigenics-us-llc-fort-worth-tx--fdaest-1649518-2026-08-19)
- [Sterigenics US LLC (contract sterilizer, Grand Prairie, TX): 15 new FDA device listings, incl. tape and bandage, adhesive](/report/deviceestablishmentpulse/sterigenics-us-llc-grand-prairie-tx--fdaest-3004111573-2026-08-12)
- [Swiss-American CDMO,LLC (contract manufacturer, Carrollton, TX): 4 new FDA device listings, incl. dressing, wound, drug](/report/deviceestablishmentpulse/swiss-american-cdmo-llc-carrollton-tx--fdaest-1649690-2026-10-12)
- [Van Sickle Surgical Instruments, Inc. (repackager or relabeler, Hurst, TX): 3 new FDA device listings, incl. saw, nasal](/report/deviceestablishmentpulse/van-sickle-surgical-instruments-inc-hurst-tx--fdaest-3034688516-2026-05-29)
- [Viant San Antonio, Inc. (contract manufacturer, San Antonio, TX): 4 new FDA device listings, incl. temporarily implanted peripheral nerve stimulation system for sustaine](/report/deviceestablishmentpulse/viant-san-antonio-inc-san-antonio-tx--fdaest-3013404959-2026-08-31)

## TH

- [Avita Corp (Thailand) Co., Ltd. (manufacturer, Chonburi Chon Buri, TH): 5 new FDA device listings, incl. pad, heating, powered](/report/deviceestablishmentpulse/avita-corp-thailand-co-ltd-chonburi-chon-buri-th--fdaest-3042156936-2026-05-29)
- [Epic International (Thailand) Co., Ltd. (manufacturer, Amphur Pluakdaeng Rayong, TH): 6 new FDA device listings, incl. controller, infusion, intravascular, electronic](/report/deviceestablishmentpulse/epic-international-thailand-co-ltd-amphur-pluakdaeng-rayong-th--fdaest-3012429465-2026-09-10)
- [Excellent Medical Technology (Thailand) Co., Ltd. (contract manufacturer, U-Thai District Phra Nakhon Si Ayutthaya, TH): 5 new FDA device listings, incl. garment, protective, for incontinence](/report/deviceestablishmentpulse/excellent-medical-technology-thailand-co-ltd-u-thai-district-phra-nakhon-si-th--fdaest-3019798849-2026-09-08)
- [Huana Technology (Thailand) Co., Ltd. (manufacturer, Bang Pakong Chachoengsao, TH): 2 new FDA device listings, incl. catheter and tip, suction](/report/deviceestablishmentpulse/huana-technology-thailand-co-ltd-bang-pakong-chachoengsao-th--fdaest-3038611387-2026-08-28)
- [Infus Medical (Thailand) Co., Ltd. (contract manufacturer, Amphoe Muang Samutprakarn Samut Prakan, TH): 3 new FDA device listings, incl. gynecologic power morcellator and containment system](/report/deviceestablishmentpulse/infus-medical-thailand-co-ltd-amphoe-muang-samutprakarn-samu-th--fdaest-9680340-2026-09-07)
- [Molex (Thailand) Ltd. (contract manufacturer, Bangpakong Chachoengsao, TH): 5 new FDA device listings, incl. stimulator, spinal-cord, totally implanted for pain relief](/report/deviceestablishmentpulse/molex-thailand-ltd-bangpakong-chachoengsao-th--fdaest-3012693387-2026-08-14)
- [Puli Healthcare (Thailand) Co., Ltd. (manufacturer, Bangkok Samut Prakan, TH): 29 new FDA device listings, incl. gauze / sponge,nonresorbable for external use](/report/deviceestablishmentpulse/puli-healthcare-thailand-co-ltd-bangkok-samut-prakan-th--fdaest-3045742729-2026-06-02)
- [STERIS TOMOE (Thailand) Ltd. (contract sterilizer, Chonburi Chon Buri, TH): 4 new FDA device listings, incl. fentanyl and other opioid protection glove](/report/deviceestablishmentpulse/steris-tomoe-thailand-ltd-chonburi-chon-buri-th--fdaest-3017616393-2026-10-14)
- [Tianyi Medical (Thailand) Co., Ltd. (contract manufacturer, PLUAKDAENG DISTRICT Rayong, TH): 2 new FDA device listings, incl. syringe, piston](/report/deviceestablishmentpulse/tianyi-medical-thailand-co-ltd-pluakdaeng-district-rayong-th--fdaest-3042158867-2026-09-02)

## TR

- [Burak Global Ic Ve Dis Tic Ltd Sti (foreign exporter, Kocasinan Kayseri, TR): 10 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/burak-global-ic-ve-dis-tic-ltd-sti-kocasinan-kayseri-tr--fdaest-3014461810-2026-07-02)
- [Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti (foreign exporter, Maltepe Istanbul, TR): 10 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/cardimed-asia-medikal-sanayi-ve-ticaret-ltd-sti-maltepe-istanbul-tr--fdaest-3015453963-2026-09-10)
- [Mikron Makina Sanayi Ve Ticaret Ltd. Sti. (manufacturer, Ivedik Ankara, TR): 3 new FDA device listings, incl. screw, fixation, bone](/report/deviceestablishmentpulse/mikron-makina-sanayi-ve-ticaret-ltd-sti-ivedik-ankara-tr--fdaest-3010646402-2026-08-31)
- [Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi (foreign exporter, Cankaya Ankara, TR): 9 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/mka-medikal-ic-ve-dis-ticaret-sanayi-limited-sirketi-cankaya-ankara-tr--fdaest-3014279513-2026-10-17)
- [Zumrut Lens Saglik Hizm. Ve Optik Ur. Dis. Tic. Ltd. Sti. (foreign exporter, FATIH Istanbul, TR): 4 new FDA device listings, incl. lens, contact, (disposable)](/report/deviceestablishmentpulse/zumrut-lens-saglik-hizm-ve-optik-ur-dis-tic-ltd-sti-fatih-istanbul-tr--fdaest-3036689755-2026-06-16)

## TW

- [Astron Medtech Co., Ltd. (repackager or relabeler, Taipei, TW): 5 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene](/report/deviceestablishmentpulse/astron-medtech-co-ltd-taipei-tw--fdaest-3044423486-2026-07-03)
- [Hukui Biotechnology Co., Ltd. (contract manufacturer, Zhubei City Hsinchu(County), TW): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/hukui-biotechnology-co-ltd-zhubei-city-hsinchu-county-tw--fdaest-3016842138-2026-05-12)
- [Intai Technology Corp. (contract manufacturer, Taichung City, TW): 2 new FDA device listings, incl. endoscopic tissue approximation device](/report/deviceestablishmentpulse/intai-technology-corp-taichung-city-tw--fdaest-3004450679-2026-08-19)
- [Leltek Inc. (contract manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/leltek-inc-new-taipei-city-tw--fdaest-3014555455-2026-09-03)
- [Miing Wei Co., Ltd. (contract manufacturer, Tsao-Twon Nantou, TW): 4 new FDA device listings, incl. intervertebral fusion device with bone graft, cervical](/report/deviceestablishmentpulse/miing-wei-co-ltd-tsao-twon-nantou-tw--fdaest-3030183061-2026-09-12)
- [New Deantronics Taiwan Ltd. (contract manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. appliance, fixation, nail/blade/plate combination, multiple component](/report/deviceestablishmentpulse/new-deantronics-taiwan-ltd-new-taipei-city-tw--fdaest-9681191-2026-06-17)
- [Pegavision Corporation (manufacturer, Taoyuan, TW): 4 new FDA device listings, incl. lenses, soft contact, daily wear](/report/deviceestablishmentpulse/pegavision-corporation-taoyuan-tw--fdaest-3010392968-2026-07-17)
- [Pegavision Corporation-Daxi (manufacturer, Taoyuan City, TW): 4 new FDA device listings, incl. lenses, soft contact, daily wear](/report/deviceestablishmentpulse/pegavision-corporation-daxi-taoyuan-city-tw--fdaest-3018616050-2026-07-17)
- [Savfe Co., Ltd. (manufacturer, New Taipei City, TW): 3 new FDA device listings, incl. system, image processing, radiological](/report/deviceestablishmentpulse/savfe-co-ltd-new-taipei-city-tw--fdaest-3047907228-2026-06-30)
- [Syntec Scientific Corp. (contract manufacturer, CHANG HUA Changhua, TW): 6 new FDA device listings, incl. shoulder prosthesis, reverse configuration](/report/deviceestablishmentpulse/syntec-scientific-corp-chang-hua-changhua-tw--fdaest-9616944-2026-05-28)
- [Taiwan Surgical Corporation (manufacturer, Zhubei City Hsinchu(County), TW): 3 new FDA device listings, incl. applier, surgical, clip](/report/deviceestablishmentpulse/taiwan-surgical-corporation-zhubei-city-hsinchu-county-tw--fdaest-3010605922-2026-07-21)
- [United Orthopedic Corp. (manufacturer, Kaohsiung, TW): 4 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented](/report/deviceestablishmentpulse/united-orthopedic-corp-kaohsiung-tw--fdaest-9681642-2026-09-03)
- [United Orthopedic Corporation (manufacturer, Hsinchu Hsinchu(County), TW): 4 new FDA device listings, incl. prosthesis, hip, semi-constrained, metal/polymer, porous uncemented](/report/deviceestablishmentpulse/united-orthopedic-corporation-hsinchu-hsinchu-county-tw--fdaest-3012329926-2026-09-03)
- [Valentine Intl. Ltd. (manufacturer, Hsichih City, Taipei Hsien, TW): 3 new FDA device listings, incl. hook, external limb component, mechanical](/report/deviceestablishmentpulse/valentine-intl-ltd-hsichih-city-taipei-hsien-tw--fdaest-8022890-2026-06-15)
- [Zimmer Biomet Taiwan Co., Ltd. (foreign exporter, Taipei, TW): 22 new FDA device listings, incl. plate, fixation, bone](/report/deviceestablishmentpulse/zimmer-biomet-taiwan-co-ltd-taipei-tw--fdaest-3011683674-2026-08-13)

## Utah

- [Acme United Corporation - My Medic (repackager or relabeler, North Salt Lake, UT): 3 new FDA device listings, incl. airway, nasopharyngeal](/report/deviceestablishmentpulse/acme-united-corporation-my-medic-north-salt-lake-ut--fdaest-3015544945-2026-08-24)
- [Aseptikits, LLC (repackager or relabeler, North Salt Lake, UT): 5 new FDA device listings, incl. syringe, piston](/report/deviceestablishmentpulse/aseptikits-llc-north-salt-lake-ut--fdaest-3015422213-2026-06-24)
- [Bard Access Systems, Inc. (other, Salt Lake City, UT): 14 new FDA device listings, incl. catheter, umbilical artery](/report/deviceestablishmentpulse/bard-access-systems-inc-salt-lake-city-ut--fdaest-3006260740-2026-08-14)
- [Centerpoint Systems LLC (manufacturer, West Valley City, UT): 4 new FDA device listings, incl. introducer, catheter](/report/deviceestablishmentpulse/centerpoint-systems-llc-west-valley-city-ut--fdaest-3015970743-2026-09-01)
- [HyperFlex Medical Inc (specification developer, Richmond, UT): 2 new FDA device listings, incl. instrument, compression](/report/deviceestablishmentpulse/hyperflex-medical-inc-richmond-ut--fdaest-3038503572-2026-09-17)
- [INNO Holdings Inc. (manufacturer, Millcreek, UT): 3 new FDA device listings, incl. intervertebral fusion device with integrated fixation, lumbar](/report/deviceestablishmentpulse/inno-holdings-inc-millcreek-ut--fdaest-3004719693-2026-10-05)
- [Isomedix Operations Inc. (contract sterilizer, Sandy, UT): 13 new FDA device listings, incl. plate, fixation, bone](/report/deviceestablishmentpulse/isomedix-operations-inc-sandy-ut--fdaest-1720929-2026-10-15)
- [Laser Marketing Group, LLC (repackager or relabeler, Lehi, UT): 5 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories](/report/deviceestablishmentpulse/laser-marketing-group-llc-lehi-ut--fdaest-3009736547-2026-08-07)
- [Live Tulani, LLC (repackager or relabeler, Farmington, UT): 6 new FDA device listings, incl. system, test, blood glucose, over the counter](/report/deviceestablishmentpulse/live-tulani-llc-farmington-ut--fdaest-3045951983-2026-05-29)
- [Medron, LLC (contract manufacturer, Salt Lake City, UT): 2 new FDA device listings, incl. midline catheter](/report/deviceestablishmentpulse/medron-llc-salt-lake-city-ut--fdaest-1722746-2026-09-14)
- [Merit Medical Systems, Inc. (manufacturer, South Jordan, UT): 7 new FDA device listings, incl. endoscopic access overtube, gastroenterology-urology](/report/deviceestablishmentpulse/merit-medical-systems-inc-south-jordan-ut--fdaest-1721504-2026-08-20)
- [Sterigenics U.S., LLC (contract sterilizer, Salt Lake City, UT): 51 new FDA device listings, incl. system, ablation, microwave and accessories](/report/deviceestablishmentpulse/sterigenics-u-s-llc-salt-lake-city-ut--fdaest-1721676-2026-07-21)
- [Total Joint Orthopedics, Inc. (specification developer, Salt Lake City, UT): 2 new FDA device listings, incl. prosthesis, knee, patellofemorotibial, semi-constrained, cemented, pol](/report/deviceestablishmentpulse/total-joint-orthopedics-inc-salt-lake-city-ut--fdaest-3008544874-2026-09-11)
- [Ultradent Products Inc. (manufacturer, South Jordan, UT): 3 new FDA device listings, incl. varnish, cavity](/report/deviceestablishmentpulse/ultradent-products-inc-south-jordan-ut--fdaest-1718912-2026-08-26)
- [Zigg Design LLC (contract manufacturer, Nibley, UT): 33 new FDA device listings, incl. orthosis, spine, plate, laminoplasty, metal](/report/deviceestablishmentpulse/zigg-design-llc-nibley-ut--fdaest-3009957608-2026-09-21)

## Virginia

- [Avid Medical, Inc. A Medical Action Ind. Company 305 (manufacturer, Toano, VA): 4 new FDA device listings, incl. truss, umbilical](/report/deviceestablishmentpulse/avid-medical-inc-a-medical-action-ind-company-305-toano-va--fdaest-1047429-2026-09-16)
- [Intent Brands LLC (repackager or relabeler, Falls Church, VA): 9 new FDA device listings, incl. lubricant, patient](/report/deviceestablishmentpulse/intent-brands-llc-falls-church-va--fdaest-3031288561-2026-09-01)
- [Mfg One, LLC (contract manufacturer, Chantilly, VA): 6 new FDA device listings, incl. warmer, thermal, infusion fluid](/report/deviceestablishmentpulse/mfg-one-llc-chantilly-va--fdaest-3004167615-2026-07-09)
- [S. Jackson, Inc. (manufacturer, Alexandria, VA): 4 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyamide](/report/deviceestablishmentpulse/s-jackson-inc-alexandria-va--fdaest-1111225-2026-08-10)

## VN

- [Anctek Viet Nam Company Limited (contract manufacturer, Bien Hoa Dong Nai, VN): 3 new FDA device listings, incl. light based over the counter wrinkle reduction](/report/deviceestablishmentpulse/anctek-viet-nam-company-limited-bien-hoa-dong-nai-vn--fdaest-3048086714-2026-08-18)
- [B And B Investment Company Limited (foreign exporter, Ha Dong Ward Ha Noi, VN): 12 new FDA device listings, incl. tubes, vacuum sample, with anticoagulant](/report/deviceestablishmentpulse/b-and-b-investment-company-limited-ha-dong-ward-ha-noi-vn--fdaest-3042871620-2026-07-30)
- [Basic International Viet Nam Co.,Ltd (manufacturer, QUANG TRUNG WARD Thanh Hoa, VN): 4 new FDA device listings, incl. medical glove, specialty](/report/deviceestablishmentpulse/basic-international-viet-nam-co-ltd-quang-trung-ward-thanh-hoa-vn--fdaest-3038276166-2026-07-17)
- [Comatrix Technology Vietnam Company Limited (contract manufacturer, Ho Chi Minh City, VN): 11 new FDA device listings, incl. joint, knee, external brace](/report/deviceestablishmentpulse/comatrix-technology-vietnam-company-limited-ho-chi-minh-city-vn--fdaest-3044707950-2026-06-05)
- [Cometech Vn Company Limited (contract manufacturer, Phu Thanh Ward Ho Chi Minh, VN): 7 new FDA device listings, incl. teeth, artificial, posterior with metal insert](/report/deviceestablishmentpulse/cometech-vn-company-limited-phu-thanh-ward-ho-chi-minh-vn--fdaest-3048547325-2026-08-31)
- [Environstar Group Company Limited (contract manufacturer, Hung Yen Province, VN): 2 new FDA device listings, incl. gown, surgical](/report/deviceestablishmentpulse/environstar-group-company-limited-hung-yen-province-vn--fdaest-3017467279-2026-08-26)
- [MZ Vietnam Co.,LTD (contract manufacturer, tan thuan ward Ho Chi Minh, VN): 4 new FDA device listings, incl. accessories, wheelchair](/report/deviceestablishmentpulse/mz-vietnam-co-ltd-tan-thuan-ward-ho-chi-minh-vn--fdaest-3041391447-2026-06-23)
- [Nam Ha Viet Nam Trading Company Limited (repackager or relabeler, Hanoi Ha Noi, VN): 3 new FDA device listings, incl. set, administration, intravascular](/report/deviceestablishmentpulse/nam-ha-viet-nam-trading-company-limited-hanoi-ha-noi-vn--fdaest-3018507299-2026-09-24)
- [Ogawa Wellness Vietnam Company Limited (manufacturer, Long An, VN): 2 new FDA device listings, incl. over-the-counter powered light based laser for acne](/report/deviceestablishmentpulse/ogawa-wellness-vietnam-company-limited-long-an-vn--fdaest-3033435469-2026-09-25)
- [Phu Bao Medical Co., Ltd (manufacturer, Long An Province, VN): 2 new FDA device listings, incl. mask, surgical](/report/deviceestablishmentpulse/phu-bao-medical-co-ltd-long-an-province-vn--fdaest-3016615220-2026-08-21)
- [S&S Glove Corporation (manufacturer, Ho Chi Minh City, VN): 4 new FDA device listings, incl. medical glove, specialty](/report/deviceestablishmentpulse/s-and-s-glove-corporation-ho-chi-minh-city-vn--fdaest-3021015522-2026-06-30)
- [S&S Glove Corporation- Branch 1 (contract manufacturer, Ho Chi Minh City Ba Ria-Vung Tau, VN): 4 new FDA device listings, incl. fentanyl and other opioid protection glove](/report/deviceestablishmentpulse/s-and-s-glove-corporation-branch-1-ho-chi-minh-city-ba-ria-vung-t-vn--fdaest-3028652705-2026-06-25)
- [Tam Viet Distribution Company Limited (foreign exporter, Ho Chi Minh, VN): 17 new FDA device listings, incl. set, administration, intravascular](/report/deviceestablishmentpulse/tam-viet-distribution-company-limited-ho-chi-minh-vn--fdaest-3015276780-2026-10-16)
- [Thanh Hoa Medical Technology Co., Ltd. (manufacturer, QUANG TRUNG WARD Thanh Hoa, VN): 4 new FDA device listings, incl. medical gloves with chemotherapy labeling claims - test for use with c](/report/deviceestablishmentpulse/thanh-hoa-medical-technology-co-ltd-quang-trung-ward-thanh-hoa-vn--fdaest-3038277359-2026-07-16)
- [Viemedi Global Co., Ltd. (contract manufacturer, Vinh Tan Ward Ho Chi Minh, VN): 2 new FDA device listings, incl. sleeve, limb, compressible](/report/deviceestablishmentpulse/viemedi-global-co-ltd-vinh-tan-ward-ho-chi-minh-vn--fdaest-3049105591-2026-09-03)
- [WU'S TECH (VIETNAM) Co., Ltd. (contract manufacturer, Ho Chi Minh City Binh Duong, VN): 2 new FDA device listings, incl. wheelchair, powered](/report/deviceestablishmentpulse/wu-s-tech-vietnam-co-ltd-ho-chi-minh-city-binh-duong-vn--fdaest-3007963811-2026-09-11)
- [Yong Yi Viet Nam Co.,Ltd (contract manufacturer, Duc Hoa Commune Tay Ninh, VN): 2 new FDA device listings, incl. adaptor, dressing](/report/deviceestablishmentpulse/yong-yi-viet-nam-co-ltd-duc-hoa-commune-tay-ninh-vn--fdaest-3015526491-2026-09-10)

## Washington

- [Acme United Corp. (repackager or relabeler, Vancouver, WA): 2 new FDA device listings, incl. dressing, wound, occlusive](/report/deviceestablishmentpulse/acme-united-corp-vancouver-wa--fdaest-3023917-2026-08-16)
- [Fujifilm Sonosite,Inc. (manufacturer, Bothell, WA): 3 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/fujifilm-sonosite-inc-bothell-wa--fdaest-3032367-2026-07-14)
- [Mackay Manufacturing, Inc. (contract manufacturer, Spokane Valley, WA): 11 new FDA device listings, incl. orthopedic stereotaxic instrument](/report/deviceestablishmentpulse/mackay-manufacturing-inc-spokane-valley-wa--fdaest-3003935342-2026-08-17)
- [Philips Ultrasound LLC (manufacturer, Bothell, WA): 36 new FDA device listings, incl. catheter, ultrasound, intravascular](/report/deviceestablishmentpulse/philips-ultrasound-llc-bothell-wa--fdaest-3019216-2026-09-30)
- [Siemens Medical Solutions USA, Inc. (manufacturer, Issaquah, WA): 7 new FDA device listings, incl. biopsy needle guide kit](/report/deviceestablishmentpulse/siemens-medical-solutions-usa-inc-issaquah-wa--fdaest-3023245-2026-09-14)

## West Virginia

- [Alcon Research, LLC (manufacturer, Huntington, WV): 3 new FDA device listings, incl. extended depth of focus intraocular lens](/report/deviceestablishmentpulse/alcon-research-llc-huntington-wv--fdaest-1119421-2026-07-07)
- [Alcon Research, LLC (manufacturer, Lesage, WV): 3 new FDA device listings, incl. lens, intraocular, toric optics](/report/deviceestablishmentpulse/alcon-research-llc-lesage-wv--fdaest-3007530141-2026-07-07)

## Wisconsin

- [Datex-Ohmeda, Inc. (specification developer, Waukesha, WI): 3 new FDA device listings, incl. system, monitoring, perinatal](/report/deviceestablishmentpulse/datex-ohmeda-inc-waukesha-wi--fdaest-3036470679-2026-09-09)
- [GE Medical Systems Information Technologies, Inc. (specification developer, Waukesha, WI): 26 new FDA device listings, incl. analyzer, gas, carbon-dioxide, gaseous-phase](/report/deviceestablishmentpulse/ge-medical-systems-information-technologies-inc-waukesha-wi--fdaest-3001570235-2026-08-06)
- [GE Medical Systems Information Technologies, Inc. (specification developer, Wauwatosa, WI): 26 new FDA device listings, incl. analyzer, gas, carbon-dioxide, gaseous-phase](/report/deviceestablishmentpulse/ge-medical-systems-information-technologies-inc-wauwatosa-wi--fdaest-3012359877-2026-08-06)
- [GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC (specification developer, Waukesha, WI): 4 new FDA device listings, incl. transducer, ultrasonic, diagnostic](/report/deviceestablishmentpulse/ge-medical-systems-ultrasound-and-primary-care-diagnostics-waukesha-wi--fdaest-3032008018-2026-08-10)
- [Ge Medical Systems, LLC (specification developer, Waukesha, WI): 3 new FDA device listings, incl. system, nuclear magnetic resonance imaging](/report/deviceestablishmentpulse/ge-medical-systems-llc-waukesha-wi--fdaest-2183553-2026-10-06)
- [Hm Product Solutions, Ltd. (contract manufacturer, Hartland, WI): 3 new FDA device listings, incl. system, x-ray, tomography, computed](/report/deviceestablishmentpulse/hm-product-solutions-ltd-hartland-wi--fdaest-3008355361-2026-07-14)
- [Icp, Inc. (specification developer, Green Bay, WI): 5 new FDA device listings, incl. band, elastic, orthodontic](/report/deviceestablishmentpulse/icp-inc-green-bay-wi--fdaest-2132509-2026-05-21)
- [Inter-Med, Inc. (manufacturer, Racine, WI): 3 new FDA device listings, incl. cement, dental](/report/deviceestablishmentpulse/inter-med-inc-racine-wi--fdaest-2133714-2026-06-29)
- [Merz North America, Inc. (other, Sturtevant, WI): 4 new FDA device listings, incl. implant, dermal, for aesthetic use](/report/deviceestablishmentpulse/merz-north-america-inc-sturtevant-wi--fdaest-3013840437-2026-09-23)
- [Performance Health Supply, LLC. (specification developer, Cedarburg, WI): 3 new FDA device listings, incl. esthesiometer](/report/deviceestablishmentpulse/performance-health-supply-llc-cedarburg-wi--fdaest-2128677-2026-09-23)
- [Uline, Inc. (repackager or relabeler, Pleasant Prairie, WI): 4 new FDA device listings, incl. latex patient examination glove](/report/deviceestablishmentpulse/uline-inc-pleasant-prairie-wi--fdaest-3002661124-2026-07-10)

## ZA

- [Coba Biomedical PTY (Ltd) (contract manufacturer, Bloemfontein Free State, ZA): 27 new FDA device listings, incl. hook, ophthalmic](/report/deviceestablishmentpulse/coba-biomedical-pty-ltd-bloemfontein-free-state-za--fdaest-3042940336-2026-06-02)

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