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
70537–70560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 02, 2003
DIGITAL IMAGER
K032022 · LMA
Pyramid Medical, Inc.
Radiology · 64d
Cleared Sep 02, 2003
ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD...
K032156 · IYE
Wfr/Aquaplast Corp.
Radiology · 50d
Cleared Sep 02, 2003
VP-1000
K032544 · FET
Mgb Endoskopische Gerate GmbH (Berlin)
Gastroenterology & Urology · 15d
Cleared Sep 02, 2003
ENDOSCOPIC LIGHT SOURCE LS-3000X
K032545 · FET
Mgb Endoskopische Gerate GmbH (Berlin)
Gastroenterology & Urology · 15d
Cleared Aug 29, 2003
V SET
K020419 · FPA
P.T. Greenleaf
General Hospital · 568d
Cleared Aug 29, 2003
V SET
K020424 · FPA
Hennig Enterprises Europe Srl
General Hospital · 567d
Cleared Aug 29, 2003
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K024313 · MNI
Pisharodi Surgicals, Inc.
Orthopedic · 248d
Cleared Aug 29, 2003
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
K030066 · KPT
Nuclear Associates
Radiology · 234d
Cleared Aug 29, 2003
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
K030237 · KWI
Kapp Surgical Instrument, Inc.
Orthopedic · 218d