FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82489–82512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
K000308 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 108d
Cleared May 19, 2000
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
K000637 · NCF
Alcon Laboratories, Inc.
Ophthalmic · 84d
Cleared May 19, 2000
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
K000704 · GBX
Dmc Medical, Ltd.
General & Plastic Surgery · 78d
Cleared May 19, 2000
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND...
K000723 · KOD
Rochester Medical Corp.
Gastroenterology & Urology · 74d
Cleared May 19, 2000
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K000729 · DSP
Arrow Intl., Inc.
Cardiovascular · 74d
Cleared May 19, 2000
SOFTFORM FACIAL IMPLANT
K000849 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 65d
Cleared May 19, 2000
C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3,...
K000894 · EBG
Dental Ventures of America, Inc.
Dental · 60d
Cleared May 19, 2000
KAWASUMI LABORATORY BLOOD DRAWING KIT
K001043 · KSB
Kawasumi Laboratories America, Inc.
Hematology · 49d
Cleared May 19, 2000
POLYMACON
K001089 · LPL
CooperVision, Inc.
Ophthalmic · 45d
Cleared May 19, 2000
METHAFILCON A
K001090 · LPL
CooperVision, Inc.
Ophthalmic · 45d
Cleared May 19, 2000
ROVERS ENDOCERVEX-BRUSH
K001119 · HHT
Rovers Medical Devices B.V.
Obstetrics & Gynecology · 42d
Cleared May 19, 2000
MALE LATEX COMDOM WITH DOTTED SURFACE
K001221 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 32d
Cleared May 19, 2000
PROAIR 3000 COMPRESSION SYSTEM
K993758 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 196d
Cleared May 19, 2000
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
K994188 · CBQ
Agilent Technologies, GmbH
Anesthesiology · 158d
Cleared May 18, 2000
ETEST MOXIFLOXACIN
K000298 · JWY
Ab Biodisk
Microbiology · 108d
Cleared May 18, 2000
STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
K000611 · GKZ
Bd Biosciences
Hematology · 85d
Cleared May 18, 2000
APEXPRO TELEMETRY SYSTEM
K000779 · DSI
General Electric Medical Systems...
Cardiovascular · 69d
Cleared May 18, 2000
THE CARDIAC READER SYSTEM
K000784 · MMI
Roche Diagnostics Corp.
Chemistry · 69d
Cleared May 18, 2000
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
K000903 · KLT
Bayer Corp.
Chemistry · 58d
Cleared May 18, 2000
BAYER ADVIA IMS SYSTEM
K000921 · DER
Bayer Corp.
Chemistry · 57d
Cleared May 18, 2000
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
K001086 · CDZ
Diagnostic Systems Laboratories, Inc.
Immunology · 44d
Cleared May 18, 2000
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
K001098 · FMI
Pro. Duct Health, Inc.
Pathology · 44d
Cleared May 18, 2000
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP),...
K001237 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 30d
Cleared May 18, 2000
INTRACOIL STENT
K001257 · JCT
Intratherapeutics, Inc.
General & Plastic Surgery · 29d