FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167593–167616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 04, 1980
RENAL SYSTEMS HEMODIALYSIS CONCENTRATE
K792213 · KPO
Renal Systems, Inc.
Gastroenterology & Urology · 63d
Cleared Jan 04, 1980
TEETH, DENTURE, PLASTIC
K792245 · ELM
Dentsply Intl.
Dental · 58d
Cleared Jan 04, 1980
CMS 6000
K792380 · GYE
Physio-Control Corp.
Neurology · 39d
Cleared Jan 04, 1980
OPERATING TABLES & AMPLINOX 03
K792569 · BWN
Ets Rene Marzet
General & Plastic Surgery · 22d
Cleared Jan 04, 1980
ENDOVAGE SYRINGE
K792577 · EIC
Dental Development Services, Inc.
Dental · 21d
Cleared Jan 04, 1980
EPIC CANNULA
K792578 · EIC
Dental Development Services, Inc.
Dental · 21d