Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
74305–74328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681 · DQO
Boston Scientific Corp
Cardiovascular · 25d
Cleared Nov 26, 2002
CANON FULL AUTO TONOMETER TX-F
K023816 · HKX
Canon, Inc.-Utsunomiya Optical...
Ophthalmic · 11d
Cleared Nov 25, 2002
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
K022686 · FED
Lap Surgical Systems, LLC
Gastroenterology & Urology · 104d
Cleared Nov 25, 2002
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
K022800 · DHN
Hyperion, Inc.
Immunology · 94d
Cleared Nov 25, 2002
FOTONA TANDEM LASER SYSTEM
K022837 · GEX
Fotona D.D.
General & Plastic Surgery · 90d
Cleared Nov 25, 2002
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM
K022838 · GEX
Fotona D.D.
General & Plastic Surgery · 90d
Cleared Nov 25, 2002
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
K022839 · GEX
Fotona D.D.
General & Plastic Surgery · 90d
Cleared Nov 25, 2002
ENDOTACK
K022853 · MBI
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 90d
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