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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68833–68856 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2004
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
K033761 · HCG
Biocompatibles UK Limited
Neurology · 64d
Cleared Feb 04, 2004
MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
K033813 · HCG
Micrus Corp.
Neurology · 57d
Cleared Feb 04, 2004
THERMAGE THERMACOOL SYSTEM
K033942 · GEI
Thermage, Inc.
General & Plastic Surgery · 47d
Cleared Feb 04, 2004
PERIFIX CATHETER CONNECTOR
K033952 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 44d
Cleared Feb 04, 2004
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV...
K033969 · LPL
Vistakon
Ophthalmic · 44d
Cleared Feb 04, 2004
SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055,...
K033997 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 42d
Cleared Feb 04, 2004
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
K040024 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 28d
Cleared Feb 04, 2004
CURVED CUTTER STAPLER, MODELS CS40B, CS40G
K040038 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 27d
Cleared Feb 04, 2004
VARNISHAMERICA
K040098 · LBH
Medical Products Laboratories, Inc.
Dental · 15d
Cleared Feb 03, 2004
MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
K032593 · BXR
Mercury Medical
Anesthesiology · 165d
Cleared Feb 03, 2004
INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
K032862 · JBD
Interlab S.R.L.
Hematology · 144d
Cleared Feb 03, 2004
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...
K033036 · MOI
Beckman Coulter, Inc.
Immunology · 127d
Cleared Feb 03, 2004
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 88d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
K033784 · LON
Becton, Dickinson & CO
Microbiology · 61d
Cleared Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT...
K033889 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Feb 03, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924 · DIF
Bio-Rad Laboratories, Inc.
Chemistry · 47d
Cleared Feb 02, 2004
AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
K030849 · JJX
N-Dia, Inc.
Chemistry · 322d
Cleared Feb 02, 2004
CHASE CARDIAC ANALYSIS SYSTEM
K032531 · LLZ
Chase Medical, Inc.
Radiology · 171d
Cleared Feb 02, 2004
PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF
K032628 · IZL
United Radiology Systems, Inc.
Radiology · 160d
Cleared Feb 02, 2004
STV PRO 2
K033419 · EIA
Trophy Radiologie
Dental · 98d
Cleared Feb 02, 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · KWS
Biomet, Inc.
Orthopedic · 89d
Cleared Feb 02, 2004
BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8
K033538 · FLE
Sauter AG
General Hospital · 84d
Cleared Feb 02, 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608 · LPN
Ciba Vision Corporation
Ophthalmic · 77d
Cleared Feb 02, 2004
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
K033656 · LRX
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 73d