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
61153–61176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2006
ATB ADVANCED PTA DILATATION CATHETER
K063252 · DQY
Cook, Inc.
Cardiovascular · 18d
Cleared Nov 13, 2006
SALTO TALARIS TOTAL ANKLE PROSTHESIS
K060544 · HSN
Tornier
Orthopedic · 257d
Cleared Nov 13, 2006
IQQA-LIVER SOFTWARE
K061696 · LLZ
Edda Technology, Inc.
Radiology · 152d
Cleared Nov 13, 2006
INNOVACON SPECTRUM II TEST CARD
K061718 · DKZ
Innovacon, Inc.
Toxicology · 147d
Cleared Nov 13, 2006
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
K062434 · NBW
Agamatrix
Chemistry · 84d
Cleared Nov 13, 2006
SBI LATERAL RHEAD IMPLANT
K062898 · KWI
Small Bone Innovations, Inc.
Orthopedic · 47d
Cleared Nov 13, 2006
ORTHROPRO HEMI TOE
K062908 · KWD
Orthopro, LLC
Orthopedic · 47d
Cleared Nov 13, 2006
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
K062920 · KTW
Orthofix Srl
Orthopedic · 46d
Cleared Nov 13, 2006
MEDLINE HYPODERMIC NEEDLES
K062984 · FMI
Medline Industries, Inc.
General Hospital · 45d
Cleared Nov 13, 2006
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
K063144 · JJE
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Nov 09, 2006
KARL STORZ VIDEO GASTROSCOPES
K060907 · FDS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 220d
Cleared Nov 09, 2006
SOYALA FULL FACE MASK
K061653 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 149d
Cleared Nov 09, 2006
RIVA BOND LC
K062064 · EMA
Southern Dental Industries, Inc.
Dental · 112d
Cleared Nov 09, 2006
BINAXNOW INFLUENZA A & B TEST
K062109 · PSZ
Binax, Inc.
Microbiology · 108d
Cleared Nov 09, 2006
DIGITAL MXR-D FLOWMETER
K062155 · BSZ
Porter Instrument Co., Inc.
Anesthesiology · 104d
Cleared Nov 09, 2006
GORE PROPATEN VASCULAR GRAFT
K062161 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 104d
Cleared Nov 09, 2006
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
K062186 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 101d
Cleared Nov 09, 2006
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
K062241 · JAQ
North American Scientific, Inc.
Radiology · 99d
Cleared Nov 09, 2006
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
K062384 · KXK
Isoray, Inc.
Radiology · 86d
Cleared Nov 09, 2006
SMITHWICK CAROTID SHUNT
K062474 · DXC
Mcpherson Enterprises, Inc.
Cardiovascular · 77d
Cleared Nov 09, 2006
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
K062605 · DQA
Philips Medical Systems
Anesthesiology · 65d
Cleared Nov 09, 2006
HALO90 COAGULATION CATHETER
K062723 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 58d
Cleared Nov 09, 2006
TOMAS PIN SD 6, 8, AND 10 MM
K062733 · OAT
Dentaurum
Dental · 57d
Cleared Nov 09, 2006
INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001
K062782 · MAI
Inion OY
Orthopedic · 52d