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
81985–82008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 18, 2000
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K001335 · JDI
Exactech, Inc.
Orthopedic · 21d
Cleared May 18, 2000
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K001451 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 9d
Cleared May 18, 2000
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K992320 · LIT
Boston Scientific Corp
Cardiovascular · 311d
Cleared May 18, 2000
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD,...
K992543 · MKJ
Hewlett-Packard Co.
Cardiovascular · 293d
Cleared May 18, 2000
METAL ON METAL ACETABULAR SYSTEM
K993438 · KWA
Biomet, Inc.
Orthopedic · 219d
Cleared May 18, 2000
PALOMAR SLP 2000
K994225 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 155d
Cleared May 17, 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM...
K000121 · DFC
Beckman Coulter, Inc.
Chemistry · 120d
Cleared May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
K000155 · JZO
Roche Diagnostics Corp.
Immunology · 119d
Cleared May 17, 2000
INTERCURE LTD. RESPI-LOW
K000405 · HCC
Intercure , Ltd.
Neurology · 100d