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
73705–73728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · KWH
Osteomed Corp.
Orthopedic · 87d
Cleared Nov 25, 2002
ASCENSION SILLICONE MCP
K022892 · KYJ
Ascension Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 25, 2002
MICROHYBRID 11
K022971 · EBF
Ab Ardent
Dental · 80d
Cleared Nov 25, 2002
RADLITE TISSUE RETRACTOR SYSTEM
K022989 · FSW
Genzyme Biosurgery
General & Plastic Surgery · 77d
Cleared Nov 25, 2002
DEMETECH SILK NONABSORBABLE SUTURE
K023029 · GAP
Demetech Corp.
General & Plastic Surgery · 75d
Cleared Nov 25, 2002
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K023066 · HBB
Sodemsystems
Neurology · 70d
Cleared Nov 25, 2002
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
K023075 · JKA
Bd Vacutainer Systems Preanalyical...
Chemistry · 70d
Cleared Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · JLW
Beckman Coulter, Inc.
Chemistry · 68d
Cleared Nov 25, 2002
ALOCLAIR ORAL RINSE
K023155 · OLR
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 63d
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