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
77737–77760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2001
GENERATION 4 BONE CEMENT
K993836 · LOD
Biomet, Inc.
Orthopedic · 768d
Cleared Dec 18, 2001
SHAPEABLE DOPPLER FLOW PROBE
K002958 · ITX
Cook Vascular, Inc.
Radiology · 452d
Cleared Dec 18, 2001
HOME-AWAY SYSTEM
K004047 · CAW
In-X Corp.
Anesthesiology · 354d
Cleared Dec 18, 2001
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K010925 · CBK
Siemens Elema AB
Anesthesiology · 266d
Cleared Dec 18, 2001
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
K011907 · DWJ
Sims Level 1, Inc.
Cardiovascular · 183d
Cleared Dec 18, 2001
RAMP MYOGLOBIN ASSAY
K012040 · DDR
Response Biomedical Corp.
Chemistry · 172d
Cleared Dec 18, 2001
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
K012088 · KNW
Nastech Pharmaceutical Company, Inc.
Gastroenterology & Urology · 168d
Cleared Dec 18, 2001
NO STEP ON SITE DEUG TEST CUP
K012390 · LDJ
Drug Free Enterprises
Toxicology · 144d
Cleared Dec 18, 2001
AURIS AEP
K012415 · GWJ
Synapsys, Inc.
Neurology · 141d
Cleared Dec 18, 2001
DATACAPTOR
K013019 · MWI
Capsule Technologie
Cardiovascular · 102d
Cleared Dec 18, 2001
STELLARTECH COAGULATION SYSTEM
K013139 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 90d
Cleared Dec 18, 2001
DC-UIBC-CO2-CAL, MODEL SE-153
K013178 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 85d
Cleared Dec 18, 2001
SPIRIT 300
K013251 · BYJ
Caire, Inc.
Anesthesiology · 81d
Cleared Dec 18, 2001
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380 · DJG
ACON Laboratories, Inc.
Toxicology · 67d
Cleared Dec 18, 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
K013406 · LPS
Bayer Diagnostics Corp.
Chemistry · 64d
Cleared Dec 18, 2001
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
K013451 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 61d
Cleared Dec 18, 2001
INVERNESS MEDICAL EARLY PREGNANCY TEST
K013907 · LCX
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 22d
Cleared Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · DSK
Radi Medical Systems AB
Cardiovascular · 19d
Cleared Dec 18, 2001
MODIFICATION TO ALPHA DX SYSTEM
K014024 · MMI
First Medical, Inc.
Chemistry · 12d
Cleared Dec 18, 2001
MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)
K014034 · JFL
Beckman Coulter, Inc.
Chemistry · 11d
Cleared Dec 18, 2001
CRESCO TI IMPLANT CONCEPT
K981052 · DZE
Cresco TI Systems AB
Dental · 1366d
Cleared Dec 17, 2001
POLESTAR N-10
K010850 · LNH
Odin Medical Technologies , Ltd.
Radiology · 271d
Cleared Dec 17, 2001
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
K011323 · NHG
Salimetrics, LLC
Chemistry · 230d
Cleared Dec 17, 2001
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE...
K013302 · KGO
Allegiance Healthcare Corp.
General Hospital · 75d