Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
168433–168456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1980
SILAGUM
K792363 · ELW
Parkell, Inc.
Dental · 47d
Cleared Jan 09, 1980
TODD HEWITT BROTH
K792423 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 43d
Cleared Jan 09, 1980
KODAK X-OMAT M20 PROCESSOR, MODEL 2
K792434 · IWZ
Eastman Kodak Company
Radiology · 42d
Cleared Jan 09, 1980
KODAK X-OMAT M20 PROCESSOR, MODEL 1
K792435 · IWZ
Eastman Kodak Company
Radiology · 42d
Cleared Jan 09, 1980
RAFLEX 70
K792437 · EAP
Mdt Corp., Inc.
Radiology · 42d
Cleared Jan 09, 1980
ADR REAL-TIME SECTOR SCANNER
K792446 · IYO
Adr Ultrasound
Radiology · 40d
Cleared Jan 09, 1980
KODAK X-OMAT G FILM
K792448 · IWZ
Eastman Kodak Company
Radiology · 40d
Cleared Jan 09, 1980
MODEL 339 TELECROS WIRELESS BICROS
K792462 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Jan 09, 1980
MODEL 339 TELECROS WIRELESS CROS
K792463 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Jan 09, 1980
MODEL 341H (HEARING AID)
K792464 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 37d
Cleared Jan 09, 1980
RESPIRATOR DISCONNECT ALARM
K792515 · CAP
Intersect Medical Products, Inc.
Anesthesiology · 35d
Cleared Jan 09, 1980
RESPIRATOR DISCONNECT ALARM CR 201
K792516 · CAP
Intersect Medical Products, Inc.
Anesthesiology · 35d
Cleared Jan 09, 1980
KODAK X-OMAT RP FILM
K792517 · IWZ
Eastman Kodak Company
Radiology · 34d
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, W/NON-WOVEN NYLON
K792612 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 22d
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, NON-ADHERENT
K792613 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 22d
Cleared Jan 09, 1980
TRACHOETOMY SPONGE, NON-ADHERENT CELL
K792614 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 22d
Cleared Jan 09, 1980
CELLULOSE TRACHE SPONGE
K792615 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 22d
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, NON-ADHERENT W/HDPE
K792616 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 22d
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, NON-ADHERENT BARRIER
K792617 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 22d
Cleared Jan 09, 1980
TRACHEOTOMY SPONGE, NON-WOVEN DELNET
K792618 · EFQ
American Medical Disposable, Inc.
General & Plastic Surgery · 22d
Cleared Jan 09, 1980
FEEDBACK EDR SYSTEM MODEL ME-1
K792659 · HCC
Bio-Feedback Systems, Inc.
Neurology · 14d
Cleared Jan 09, 1980
FLEXI-CUP IMPLANT
K792663 · DZE
Impladent
Dental · 14d
Cleared Jan 09, 1980
CARDIAC OUTPUT COMPUTER, M-MLC-4100
K792678 · DXG
Nihon Kohden America, Inc.
Cardiovascular · 14d
Cleared Jan 04, 1980
OXIMETRIX SHAW HEMOSTATIC SURG. SYS.
K791868 · GEI
Oximetrix, Inc.
General & Plastic Surgery · 106d