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Data / Medical devices / Applicator, Ent / United States

FDA-registered makers of Applicator, Ent in the United States: 31 establishments

31 establishments in the United States are registered with the FDA to make Applicator, Ent (product code KCJ). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Applicator, Ent
Product code
KCJ
Country
United States

Makers of Applicator, Ent in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Applied Laboratories, Inc.Columbus, IN, United StatesContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
BarakaSanta Rosa, CA, United StatesManufacturer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Church & Dwight Co., Inc.Princeton, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dolor Technologies LLCSyracuse, UT, United StatesSpecification developer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Forward Science Technologies LLCHouston, TX, United StatesManufacturer0000api.fda.gov
FridaBaby LLCMiami, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Invotec International, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Isomedix Operations, IncOntario, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Neilmed Pharmaceuticals, Inc.Santa Rosa, CA, United StatesManufacturer0010api.fda.gov
Oogie Solutions LLCPotomac, MD, United StatesSpecification developer0000api.fda.gov
Pari Respiratory Equipment, Inc.Midlothian, VA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Parnell Pharmaceuticals, Inc.San Rafael, CA, United StatesSpecification developer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pneo, LLCDenton, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Rhinosystems, Inc.Brooklyn, OH, United StatesSpecification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer0000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesManufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.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
Xlear, Inc.American Fork, UT, United StatesManufacturer0000api.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.