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
126457–126480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1990
HEARING AID (ALL-IN-THE-EAR)
K900968 · ESD
Audiology of Tulsa, Inc.
Ear, Nose, Throat · 39d
Cleared Apr 10, 1990
VECTRA(TM)
K901100 · HQY
Optical Coating Laboratory, Inc.
Ophthalmic · 34d
Cleared Apr 10, 1990
OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
K901118 · LMB
Adac Laboratories
Radiology · 29d
Cleared Apr 10, 1990
OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
K901292 · ESD
Oticon Corp.
Ear, Nose, Throat · 21d
Cleared Apr 10, 1990
WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL
K901316 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Apr 10, 1990
WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL
K901317 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 20d
Cleared Apr 10, 1990
ANESTHESIA WORKSTATION
K901474 · BRY
Siemens Life Support Systems
Anesthesiology · 14d
Cleared Apr 10, 1990
MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)
K901489 · CCW
Eastmed Enterprises, Inc.
Anesthesiology · 12d
Cleared Apr 09, 1990
GUARDIAN FORCEP
K893636 · FCL
Endo-Scientific, Inc.
Gastroenterology & Urology · 332d
Cleared Apr 09, 1990
DESERET INTRAVASCULAR CATHETER
K895734 · FOZ
Deseret Medical, Inc.
General Hospital · 195d
Cleared Apr 09, 1990
ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)
K895854 · EJF
Acme-Monaco Corp.
Dental · 188d
Cleared Apr 09, 1990
KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE
K895945 · GEX
Laserscope
General & Plastic Surgery · 180d
Cleared Apr 09, 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 09, 1990
WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
K896323 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 09, 1990
SPAG PAK
K896608 · BYL
Viratek, Inc.
Anesthesiology · 139d
Cleared Apr 09, 1990
WILLI GELLER CERAMIC CREATION & SURPRISE
K900209 · EIH
Creation North America, Inc.
Dental · 82d
Cleared Apr 09, 1990
DISPOSABLE BIPOLAR COAGULATING FORCEPS
K900533 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 76d
Cleared Apr 09, 1990
PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO.
K900828 · JXR
The Perkin-Elmer Corp.
Toxicology · 47d
Cleared Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I
K901027 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 34d
Cleared Apr 09, 1990
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I
K901059 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 34d
Cleared Apr 09, 1990
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
K901107 · GDJ
United States Surgical, A Division of...
General & Plastic Surgery · 32d
Cleared Apr 09, 1990
LATEX EXAMINATION GLOVES
K901136 · LYY
Qilu (China) Good Luck Chemical...
General Hospital · 28d
Cleared Apr 09, 1990
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
K901141 · JJC
Baxter Healthcare Corp
Chemistry · 27d
Cleared Apr 09, 1990
LATEX EXAMINATION GLOVES
K901148 · LYY
Pt. Scitech Industries
General Hospital · 28d