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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
50161–50184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2010
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
K101481 · NJM
Biomers Products, LLC
Dental · 26d
Cleared Jun 23, 2010
8 CHANNEL CARDIAC PHASED ARRAY COIL
K101492 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 22d
Cleared Jun 23, 2010
ENDOFORM DENTAL TEMPLATE
K101546 · KGN
Mesynthes, Ltd.
General & Plastic Surgery · 20d
Cleared Jun 22, 2010
TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS
K090081 · NHA
Talladium Espana, SL
Dental · 526d
Cleared Jun 22, 2010
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
K092874 · LZA
Quality Gallant Sdn. Bhd.
General Hospital · 277d
Cleared Jun 22, 2010
STRYKER BIPOLAR FORCEPS
K093108 · GEI
Stryker Leibinger GmbH & Co KG
General & Plastic Surgery · 264d
Cleared Jun 22, 2010
ZQUIET MOUTHPIECE
K093407 · LRK
Sleeping Well, LLC
Dental · 232d
Cleared Jun 22, 2010
ANTI-HAV IGM
K093955 · LOL
Roche Diagnostics
Microbiology · 181d
Cleared Jun 22, 2010
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
K100388 · FST
Medical Illumination International, Inc.
General & Plastic Surgery · 126d
Cleared Jun 22, 2010
PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540
K100495 · FLL
Philips Electronics UK Limited
General Hospital · 123d
Cleared Jun 22, 2010
TINA-QUANT FERRITIN GEN. 4
K100538 · DBF
Roche Diagnostics
Immunology · 117d
Cleared Jun 22, 2010
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · KFM
Medtronic, Inc.
Cardiovascular · 109d
Cleared Jun 22, 2010
UNICEM HM
K100908 · EMA
3M Espe AG Dental Products
Dental · 82d
Cleared Jun 22, 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 64d
Cleared Jun 22, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K101137 · LYZ
Hongze Plastic Technology Co., Ltd.
General Hospital · 61d
Cleared Jun 22, 2010
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
K101138 · OBJ
Biosense Webster, Inc.
Cardiovascular · 61d
Cleared Jun 22, 2010
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ...
K101345 · DRF
Biosense Webster, Inc.
Cardiovascular · 40d
Cleared Jun 22, 2010
DUAL LUER LOCK CAP, MODEL 2C6250
K101385 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Jun 22, 2010
MLS-AC DERMA SCANNER
K101430 · NHN
Erchonia Corporation
Physical Medicine · 32d
Cleared Jun 22, 2010
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
K101451 · LZO
Omni Life Science, Inc.
Orthopedic · 28d
Cleared Jun 22, 2010
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
K101564 · OQW
Centers For Disease Control and...
Microbiology · 18d
Cleared Jun 21, 2010
FIAB SPA, MODELS F7244, F7233, F7234, F7277
K100333 · GEI
Fiab Spa
General & Plastic Surgery · 136d
Cleared Jun 21, 2010
QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
K100497 · HSB
N.M.B. Medical Applications, Ltd.
Orthopedic · 119d
Cleared Jun 21, 2010
OBSIDIAN CERAMIC BLOCKS
K100781 · EIH
Prismatik Dentalcraft, Inc.
Dental · 94d