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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103921–103944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1995
DUPONT ACA VANCOMYCIN (VANC) METHOD
K945125 · LEH
The DU Pont Co.
Toxicology · 142d
Cleared Mar 10, 1995
COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM
K946283 · JSM
Copan Diagnostics, Inc.
Microbiology · 73d
Cleared Mar 10, 1995
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K946284 · JSM
Copan Diagnostics, Inc.
Microbiology · 73d
Cleared Mar 10, 1995
COPAN VENTURI TRANSYSTEM STUARTS MEDIUM
K946285 · JSM
Copan Diagnostics, Inc.
Microbiology · 73d
Cleared Mar 10, 1995
COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM
K946286 · JSM
Copan Diagnostics, Inc.
Microbiology · 73d
Cleared Mar 10, 1995
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K946287 · JSM
Copan Diagnostics, Inc.
Microbiology · 73d
Cleared Mar 10, 1995
COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM
K946288 · JSM
Copan Diagnostics, Inc.
Microbiology · 73d
Cleared Mar 10, 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · LRM
Elias U.S.A., Inc.
Immunology · 65d
Cleared Mar 10, 1995
CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE
K950661 · GEX
Candela Laser Corp.
General & Plastic Surgery · 25d
Cleared Mar 10, 1995
DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT
K950662 · GEX
Laserscope
General & Plastic Surgery · 25d
Cleared Mar 10, 1995
MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER
K950710 · GEX
Microquartz Medical, Inc.
General & Plastic Surgery · 25d
Cleared Mar 10, 1995
CPR MICROMASK PLUS CATALOG NO 73-402
K950769 · CBP
Plasco, Inc.
Anesthesiology · 17d
Cleared Mar 10, 1995
CPR MICROSHIELD II
K950770 · CBP
Plasco, Inc.
Anesthesiology · 17d
Cleared Mar 10, 1995
DISPOSABLE ADHESIVE FACE MASK
K950771 · BSJ
Advanced Warming Systems, Inc.
Anesthesiology · 382d
Cleared Mar 09, 1995
CYPERFLO PERIPHERALLY INSERTED CATHETER
K935145 · LJS
Cyex Medical Technologies, Inc.
General Hospital · 499d
Cleared Mar 09, 1995
STAT PROFILE PLUS 9 ANALYZER
K936066 · KHP
Nova Biomedical Corp.
Chemistry · 443d
Cleared Mar 09, 1995
STAT PROFILE PLUS 10 ANALYZER
K936203 · CHL
Nova Biomedical Corp.
Chemistry · 443d
Cleared Mar 09, 1995
WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
K941350 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 353d
Cleared Mar 09, 1995
VARIOUS TUBING
K943206 · FPK
Prn Services, Inc.
General Hospital · 247d
Cleared Mar 09, 1995
CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS
K943292 · GEX
Candela Laser Corp.
General & Plastic Surgery · 244d
Cleared Mar 09, 1995
ENTAMOEBA TEST
K944791 · KHW
Techlab, Inc.
Microbiology · 162d
Cleared Mar 09, 1995
NOPROFILE OLBERT CATHETER SYSTEM
K945061 · KOD
Meadox Surgimed, Inc.
Gastroenterology & Urology · 146d
Cleared Mar 09, 1995
SLASE 210 PLUS HOLMIUM LASER SYSTEM
K945156 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 139d
Cleared Mar 09, 1995
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
K945280 · DCK
Dupont Medical Products
Immunology · 132d