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Data / Medical devices / Shield, Protective, Personnel / United States

FDA-registered makers of Shield, Protective, Personnel in the United States: 53 establishments

53 establishments in the United States are registered with the FDA to make Shield, Protective, Personnel (product code KPY). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Shield, Protective, Personnel
Product code
KPY
Country
United States

Makers of Shield, Protective, Personnel in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Infab, LLC.Camarillo, CA, United StatesManufacturer2May 1, 1990000api.fda.gov
BLOXR Solutions LLCSalt Lake City, UT, United StatesManufacturer1June 24, 2011000api.fda.gov
Aadco Medical, Inc.Randolph, VT, United StatesManufacturer0000api.fda.gov
Alimed, LLCDedham, MA, United StatesSpecification developer0000api.fda.gov
Angiosystems, Inc.Ducktown, TN, United StatesManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Anholt Technologies Inc.Avondale, PA, United StatesManufacturer0000api.fda.gov
Barrier Technologies, LLCDavie, FL, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer0000api.fda.gov
Burlington Medical, LLCNewport News, VA, United StatesManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Egg Medical, Inc.Roseville, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
F & L Medical Products LLCVandergrift, PA, United StatesManufacturer0000api.fda.gov
Fluke BiomedicalEverett, WA, United StatesManufacturer0000api.fda.gov
GT Medical Technologies, IncTempe, AZ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Huestis Machine Corp.Bristol, RI, United StatesManufacturer0000api.fda.gov
Intec Industries, Inc.Birmingham, AL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Madison Polymeric EngineeringBranford, CT, United StatesManufacturer0000api.fda.gov
Medtec LLCOrange City, IA, United StatesManufacturer0000api.fda.gov
Mirion Technologies (capintec), IncFlorham Park, NJ, United StatesManufacturer0000api.fda.gov
Molded Products Inc.Harlan, IA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Magicare Tech CorpOntario, CA, United StatesManufacturer0000api.fda.gov
Microtek Medical LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Microtek Medical LLCNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Microtek Medical LLCAlpharetta, GA, United StatesSpecification developer0000api.fda.gov
Philips Oral Healthcare, LLCBothell, WA, United StatesSpecification developer0000api.fda.gov
Plenoptika, Inc.Cambridge, MA, United StatesSpecification developer0000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Qlrad IncMiami, FL, United StatesSpecification developer0000api.fda.gov
Radiation Products Design, Inc.Albertville, MN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Radium IncorporatedWaynesboro, VA, United StatesManufacturer0000api.fda.gov
Radux Devices IncFridley, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
RAMPART IC, IncBirmingham, AL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
RAMPART IC, IncVestavia, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Reina ImagingCrystal Lake, IL, United StatesManufacturer0000api.fda.gov
Salus Scientific CorpCharleston, SC, United StatesManufacturer0000api.fda.gov
Shielding Intl., Inc.Madras, OR, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Sirtex Medical Inc.Woburn, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Standard Imaging, Inc.Middleton, WI, United StatesManufacturer0000api.fda.gov
SW Technologies Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Techno-Aide, Inc.Whites Creek, TN, United StatesManufacturer0000api.fda.gov
Trivitron Imaging Solutions IncScottsboro, AL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
TZ Medical, Inc.Tualatin, OR, United StatesManufacturer, Specification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ultralight Optics Inc.Westminster, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Wolf X-Ray CorpBattleboro, NC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Worldwide Innovations & Technologies, Inc.Lenexa, KS, United StatesManufacturer0000api.fda.gov
WestRock Converting, LLCRidgeway, VA, United StatesContract manufacturer0000api.fda.gov
Xeridiem Medical DevicesTucson, AZ, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.