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

Filters: Cleared only ×
176,076 results
71641–71664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2003
TMC ELECTRICAL SCOOTER, EASY 411
K031314 · INI
Tmc Technology Corp.
Physical Medicine · 133d
Cleared Sep 04, 2003
TMC ELECTRICAL SCOOTER, EASY 321
K031315 · INI
Tmc Technology Corp.
Physical Medicine · 133d
Cleared Sep 04, 2003
MACROPORE CARDIO-WRAP (TS)
K031785 · OMH
Macropore Biosurgery, Inc.
Cardiovascular · 86d
Cleared Sep 04, 2003
PIT & FISSURE SEALANT WITH FLUORIDE
K031811 · EBC
Harry J. Bosworth Co.
Dental · 84d
Cleared Sep 04, 2003
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
K031857 · DEM
Bayer Diagnostics Corp.
Chemistry · 80d
Cleared Sep 04, 2003
EBI XFIX DFS SYSTEM
K031919 · KTT
Ebi, L.P.
Orthopedic · 73d
Cleared Sep 04, 2003
ALANTECH GRAFT FIXATION SCREW
K031937 · HWC
Arthrocare Corp.
Orthopedic · 73d
Cleared Sep 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Sep 04, 2003
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037 · MNI
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Sep 04, 2003
WIROBOND C
K032136 · EJH
Bego U.S.A.
Dental · 55d
Cleared Sep 04, 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032457 · FGE
Cordis Corp.
Gastroenterology & Urology · 24d
Cleared Sep 04, 2003
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K032479 · JWH
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Sep 04, 2003
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
K032491 · DSB
Imagyn Medical Technologies, Inc.
Cardiovascular · 23d
Cleared Sep 04, 2003
ALEXANDER
K032493 · EJT
Ivoclar Vivadent, Inc.
Dental · 23d
Cleared Sep 03, 2003
EDWARDS DIRECTIONAL CATHETER
K030630 · DQY
Edwards Lifesciences, LLC
Cardiovascular · 188d
Cleared Sep 03, 2003
MEDRO SPD
K030652 · FIP
Usfilter/Ionpure, Inc.
Gastroenterology & Urology · 187d
Cleared Sep 03, 2003
PATHWAY ACCESS SHEATH CATHETER
K030662 · EZN
Vertelink Corporation
Gastroenterology & Urology · 184d
Cleared Sep 03, 2003
MERIT MAK (MINI ACCESS KIT)
K031691 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 93d
Cleared Sep 03, 2003
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
K031761 · JEY
Synthes (Usa)
Dental · 89d
Cleared Sep 03, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833 · MNI
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Sep 03, 2003
HOMOCYSTEINE MICROTITER PLATE ASSAY
K032012 · LPS
Diazyme Laboratories
Chemistry · 65d
Cleared Sep 03, 2003
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K032173 · HIL
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 49d
Cleared Sep 03, 2003
CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
K032345 · MUJ
Accuray, Inc.
Radiology · 35d
Cleared Sep 03, 2003
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
K032622 · DQY
Medtronic Vascular
Cardiovascular · 8d