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
71041–71064 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 02, 2003
SAFETYWAND DISPOSABLE HANDPIECE
K023722 · EJI
Spintech, Inc.
Dental · 301d
Cleared Sep 02, 2003
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
K030328 · DAP
bioMerieux, Inc.
Hematology · 214d
Cleared Sep 02, 2003
ARKIT HBA1C
K030553 · LCP
Arkray, Inc.
Chemistry · 193d
Cleared Sep 02, 2003
MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
K030633 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 186d
Cleared Sep 02, 2003
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
K031729 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Sep 02, 2003
I-STAT CARDIAC TROPONIN (CTNI) TEST
K031739 · MMI
I-Stat Corporation
Chemistry · 90d
Cleared Sep 02, 2003
ACMI M4 TELESCOPES
K031758 · FBP
Acmi Corporation
Gastroenterology & Urology · 88d
Cleared Sep 02, 2003
51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW
K032020 · LLZ
Iiyama Corporation
Radiology · 64d