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
148465–148488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1985
TRIPLE SUGAR IRON AGAR
K851597 · JSH
Preferred Micro-Media
Microbiology · 27d
Cleared May 13, 1985
CLINALYZER MODEL VX-1000
K851638 · JJE
Alpkem Corp.
Chemistry · 24d
Cleared May 13, 1985
MEDICAL EXAMINATION LIGHTS
K851742 · KZF
Burton Medical Products Corp.
General Hospital · 14d
Cleared May 13, 1985
FORTEC MI-305
K851873 · FLL
Nam Tai , Ltd.
General Hospital · 14d
Cleared May 10, 1985
PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
K842601 · HOZ
Ophthalmic Resources, Inc.
Ophthalmic · 309d
Cleared May 10, 1985
MINI-HALO CO2 LASER SYSTEM
K843915 · GEX
CooperVision, Inc.
General & Plastic Surgery · 218d
Cleared May 10, 1985
S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS
K844643 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 163d
Cleared May 10, 1985
SURGICAL LASER MICRO-TIPS
K844644 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 163d
Cleared May 10, 1985
MENTOR EXPANDER MAMMARY PROSTHESIS
K844813 · LCJ
Mentor Corp.
General & Plastic Surgery · 150d
Cleared May 10, 1985
SURGICAL POWER MAGNET
K845029 · FTC
Friedman Labs, Inc.
General & Plastic Surgery · 134d
Cleared May 10, 1985
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291 · JTZ
Remel Co.
Microbiology · 106d
Cleared May 10, 1985
PLASMA EXTRACTION SYSTEM
K850391 · JPI
Hans J. Brouwers & Assoc.
Hematology · 98d
Cleared May 10, 1985
SHEER ADHESIVE BANDAGES, STERILE
K850529 · KGX
Abco Dealers, Inc.
General & Plastic Surgery · 88d
Cleared May 10, 1985
THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY
K850543 · IWB
Atomic Energy of Canada
Radiology · 88d
Cleared May 10, 1985
WSP CODE 4315 PADTEST
K850693 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 78d
Cleared May 10, 1985
TAUCHER TUNNELER-PERIPHERAL VASCULAR SURG-INSTRUME
K850764
Aston & Aston
General & Plastic Surgery · 74d
Cleared May 10, 1985
COBAS CALIBRATOR SERUM
K850859 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared May 10, 1985
SPECTRA 1 FILTER PHOTOMETER
K850994 · JJQ
Awareness Technology, Inc.
Chemistry · 60d
Cleared May 10, 1985
SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P
K850995 · JJQ
Awareness Technology, Inc.
Chemistry · 60d
Cleared May 10, 1985
UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST
K851076 · JHI
United Biotech, Inc.
Chemistry · 53d
Cleared May 10, 1985
KEITH-A.R.V.
K851444 · KNT
Karl M. Block Co.
Gastroenterology & Urology · 29d
Cleared May 10, 1985
NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA
K851460 · BXY
Telectronics, Inc.
Anesthesiology · 29d
Cleared May 10, 1985
LD-1(IMMUNO) SEPARATION SET
K851521 · CEX
Seragen Diagnostics, Inc.
Chemistry · 25d
Cleared May 10, 1985
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K851542 · JJF
Alpkem Corp.
Chemistry · 24d