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
71665–71688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 29, 2003
APLAB, MODEL 801D0030
K030379 · MNR
Sector Medical Corp.
Anesthesiology · 205d
Cleared Aug 29, 2003
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
K030441 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 199d
Cleared Aug 29, 2003
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
K030742 · LIT
Cryo Vascular Systems, Inc.
Cardiovascular · 172d
Cleared Aug 29, 2003
OMNIPRO I'MRT
K031634 · IYE
Wellhofer Dosimetrie
Radiology · 94d
Cleared Aug 29, 2003
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
K031694 · OLW
Aspect Medical Systems, Inc.
Neurology · 88d
Cleared Aug 29, 2003
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
K031697 · GEH
Schering-Plough Healthcare Products,...
General & Plastic Surgery · 88d
Cleared Aug 29, 2003
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
K031700 · DTN
Medtronic Perfusion Systems
Cardiovascular · 88d