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
82513–82536 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 17, 2000
BELLEGLASS HP ENAMEL
K000530 · EBF
Sybron Dental Specialties, Inc.
Dental · 90d
Cleared May 17, 2000
ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
K000556 · CFR
Elan Diagnostics
Chemistry · 89d
Cleared May 17, 2000
MODIFICATION TO ENVOY PATIENT MONITOR
K000563 · MHX
Mennen Medical , Ltd.
Cardiovascular · 85d
Cleared May 17, 2000
VITA RESPONSE
K000597 · EIH
Vident
Dental · 85d
Cleared May 17, 2000
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
K000618 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 90d
Cleared May 17, 2000
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
K000690 · DRX
Minnesota Mining and Mfg. Co.
Cardiovascular · 78d
Cleared May 17, 2000
HEART 2005
K000775 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 69d
Cleared May 17, 2000
BELMONT UNIT, MODEL 2000 SERIES
K000799 · EIA
Belmont Equipment Corp.
Dental · 65d
Cleared May 17, 2000
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P...
K000812 · IKN
Neurosoft, Inc.
Neurology · 65d
Cleared May 17, 2000
ARACHNOPHLEBECTOMY NEEDLE
K000932 · GAH
Advanced Medical Products, Inc.
General & Plastic Surgery · 55d
Cleared May 17, 2000
ULTRA CATHETER SET
K001115 · LKF
Lyco Enterprises, Inc.
Obstetrics & Gynecology · 41d
Cleared May 17, 2000
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18,...
K001222 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 17, 2000
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13,...
K001224 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 17, 2000
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
K001225 · DKZ
Princeton BioMeditech Corp.
Toxicology · 30d
Cleared May 17, 2000
ALLROUND 55 LF
K001260 · EJT
J.F. Jelenko & Co., Inc.
Dental · 28d