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
53977–54000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2009
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
K083562 · KWQ
Stryker Corp.
Orthopedic · 113d
Cleared Mar 25, 2009
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055
K083792 · HWC
Medshape Solutions
General & Plastic Surgery · 96d
Cleared Mar 25, 2009
I_OPEN 0.4T
K090433 · LNH
Beijing Wandong Medical Equipment...
Radiology · 34d
Cleared Mar 25, 2009
FORUM
K090439 · NFJ
Carl Zeiss Meditec, Inc.
Ophthalmic · 33d
Cleared Mar 25, 2009
DISCOVERY ELBOW - X-SMALL
K090473 · JDC
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Mar 24, 2009
BETACHEK GLUCOSE TEST
K062187 · NBW
National Diagnostic Products
Chemistry · 966d
Cleared Mar 24, 2009
CPI RAD VISION, MODEL VZW2944XX-YY
K083224 · MQB
Communications & Power Industries...
Radiology · 141d
Cleared Mar 24, 2009
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN...
K083445 · CFN
Siemens Healthcare Diagnostics
Immunology · 123d
Cleared Mar 24, 2009
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 109d
Cleared Mar 24, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083853 · DHB
Siemens Healthcare Diagnostics
Immunology · 90d
Cleared Mar 24, 2009
BACTRACK SELECT BREATHALYZER, MODEL S80
K090067 · DJZ
Khn Solutions, LLC
Toxicology · 74d
Cleared Mar 24, 2009
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03,...
K090120 · DRF
Biosense Webster, Inc.
Cardiovascular · 62d
Cleared Mar 24, 2009
EQUIVABONE
K090310 · MQV
Etex Corp.
Orthopedic · 46d
Cleared Mar 24, 2009
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
K090623 · MQB
Canon USA, Inc.
Radiology · 15d
Cleared Mar 24, 2009
WIRELESS PORTABLE DETECTOR FD-W17
K090625 · MQB
Philips Medical Systems North America...
Radiology · 15d
Cleared Mar 23, 2009
BRIT PACS SYSTEMS
K081168 · LLZ
Brit Systems, Inc.
Radiology · 333d
Cleared Mar 23, 2009
HOYA IS INJECTOR SYSTEM
K081346 · MSS
Hoya Surgical Optics, Inc.
Ophthalmic · 313d
Cleared Mar 23, 2009
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA,...
K082439 · DXT
Shandong Weigao Medical Polymer Co.,...
Cardiovascular · 210d
Cleared Mar 23, 2009
CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
K082853 · MNR
Inspired Technologies, Inc.
Anesthesiology · 175d
Cleared Mar 23, 2009
CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
K083750 · MHX
Ge Medical Systems Information...
Cardiovascular · 96d
Cleared Mar 23, 2009
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL...
K083780 · ETA
Audio Technologies S.R.L.
Ear, Nose, Throat · 94d
Cleared Mar 23, 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 94d
Cleared Mar 23, 2009
BIOGRAPH 16 TRUE POINT SYSTEMS
K083852 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Mar 23, 2009
SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004
K083886 · DZE
Simpler One Stop
Dental · 84d