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
73201–73224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296 · DIO
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Nov 25, 2002
BD VACUTAINER SST II PLUS TUBES
K023331 · JKA
Becton, Dickinson & CO
Chemistry · 52d
Cleared Nov 25, 2002
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
K023644 · MNI
Spinal Concepts, Inc.
Orthopedic · 26d
Cleared Nov 25, 2002
AQUEOUS ACRYLIC DISPERSION 28% W/W
K023671 · LBH
Chx Technologies, Inc.
Dental · 24d
Cleared Nov 25, 2002
ECAT PET/CT
K023768 · KPS
Cti Pet Systems, Inc.
Radiology · 13d
Cleared Nov 22, 2002
INSPIRATION VENTILATOR SYSTEM
K021112 · CBK
eVent Medical, Ltd.
Anesthesiology · 231d
Cleared Nov 22, 2002
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID...
K021397 · NAJ
Biosphere Medical, Inc.
Obstetrics & Gynecology · 204d
Cleared Nov 22, 2002
804SIII
K021846 · GZJ
Body Clock Health Care, Ltd.
Neurology · 170d
Cleared Nov 22, 2002
KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX
K022057 · FMI
Kyung GI Medical Ind. Co., Ltd.
General Hospital · 151d
Cleared Nov 22, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K022746 · CHL
Nova Biomedical Corp.
Chemistry · 95d
Cleared Nov 22, 2002
COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER...
K022817 · GEX
Icn Pharmaceuticals, Inc.
General & Plastic Surgery · 88d
Cleared Nov 22, 2002
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K022827 · MBI
Linvatec Corp.
Orthopedic · 88d
Cleared Nov 22, 2002
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
K022899 · JAA
Philips Medical Systems North America...
Radiology · 80d
Cleared Nov 22, 2002
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
K022970 · LLZ
Amicas, Inc.
Radiology · 77d
Cleared Nov 22, 2002
MICROFILL 13
K022972 · EBF
Ab Ardent
Dental · 77d
Cleared Nov 22, 2002
ADHESIVE 14
K022973 · KLE
Ab Ardent
Dental · 77d
Cleared Nov 22, 2002
MICROHYBRID 12
K022974 · EBF
Ab Ardent
Dental · 77d
Cleared Nov 22, 2002
ETCHING 15
K022975 · EBF
Ab Ardent
Dental · 77d
Cleared Nov 22, 2002
CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005
K023110 · KPS
Digirad Corp.
Radiology · 64d
Cleared Nov 22, 2002
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
K023252 · DJR
Icn Biomedicals, Inc.
Toxicology · 53d
Cleared Nov 22, 2002
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
K023352 · JJY
Maine Standards Co.
Chemistry · 46d
Cleared Nov 22, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Nov 22, 2002
BLOCKING TRAY
K023636 · IYE
Southeastern Radiation Products, Inc.
Radiology · 23d
Cleared Nov 22, 2002
MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL...
K023665 · JEY
Bioplate, Inc.
Dental · 22d