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
72649–72672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2003
MODIFICATION TO FOSSA URETERAL STONE SWEEPER
K031292 · FAD
Fossa Medical, Inc.
Gastroenterology & Urology · 29d
Cleared May 22, 2003
SMART 2940 D ER: YAG LASER
K031317 · GEX
Cynosure, Inc.
General & Plastic Surgery · 27d
Cleared May 22, 2003
TEXAS T - PLATE
K031334 · HRS
Biomet, Inc.
Orthopedic · 24d
Cleared May 22, 2003
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531
K031379 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 21d
Cleared May 22, 2003
MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K031388 · CGA
Hypoguard USA, Inc.
Chemistry · 20d
Cleared May 22, 2003
DIGNITY OPHTHALMIC SURGICAL SYSTEM
K031404 · HQC
Phacor Inc., A Santen Company
Ophthalmic · 17d
Cleared May 22, 2003
CEMEX SYSTEM FAST
K031430 · LOD
Exactech, Inc.
Orthopedic · 16d
Cleared May 22, 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
K031469 · JAK
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared May 22, 2003
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE,...
K031518 · DWF
Medtronic Vascular
Cardiovascular · 7d
Cleared May 21, 2003
VARISEED 7.1
K030534 · KXK
Varian Medical Systems
Radiology · 90d
Cleared May 21, 2003
RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
K030544 · OWB
Sigma Vision, Inc.
Radiology · 90d
Cleared May 21, 2003
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K030558 · JAQ
Proxima Therapeutics, Inc.
Radiology · 89d
Cleared May 21, 2003
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K030576 · FRN
The Anspach Effort, Inc.
General Hospital · 86d
Cleared May 21, 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589 · DQY
NuMED, Inc.
Cardiovascular · 85d
Cleared May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · DQX
Boston Scientific Scimed, Inc.
Cardiovascular · 84d
Cleared May 21, 2003
MYTHOS 500
K030805 · GEX
Msq (M2) , Ltd.
General & Plastic Surgery · 69d
Cleared May 21, 2003
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812 · MHX
Datex-Ohmeda
Cardiovascular · 68d
Cleared May 21, 2003
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
K030828 · GKZ
Beckman Coulter, Inc.
Hematology · 68d
Cleared May 21, 2003
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
K031001 · FAS
Acmi Corporation
Gastroenterology & Urology · 51d
Cleared May 21, 2003
FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
K031020 · LYY
Pt. Mandiri Inti Buana
General Hospital · 51d
Cleared May 21, 2003
SPIN DOWN RAPIDFLAP
K031034 · GXN
Walter Lorenz Surgical, Inc.
Neurology · 50d
Cleared May 21, 2003
EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
K031079 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 47d
Cleared May 21, 2003
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
K031081 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 47d
Cleared May 21, 2003
EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK
K031082 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 47d