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
56281–56304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2008
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
K073702 · BTO
Lazarus Medical, LLC
Anesthesiology · 178d
Cleared Jun 26, 2008
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
K080734 · BTY
Viasys Healthcare GmbH
Anesthesiology · 104d
Cleared Jun 26, 2008
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
K081146 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 65d
Cleared Jun 26, 2008
PLATELIA LYME IGM
K081362 · LSR
Bio-Rad
Microbiology · 42d
Cleared Jun 26, 2008
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K081467 · QEY
Ekos Corp.
Cardiovascular · 30d
Cleared Jun 25, 2008
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603 · DHX
Dade Behring, Inc.
Immunology · 379d
Cleared Jun 25, 2008
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
K080381 · LAF
Quest Diagnostics, Inc.
Toxicology · 133d
Cleared Jun 25, 2008
ULTIMED ULTICARE SAFETY SYRINGE
K080600 · MEG
Ultimed, Inc.
General Hospital · 114d
Cleared Jun 25, 2008
HEMOCCULT ICT
K080812 · KHE
Beckman Coulter, Inc.
Hematology · 93d
Cleared Jun 25, 2008
LITE WAND II
K080962 · FST
Thompson Surgical Instruments, Inc.
General & Plastic Surgery · 82d
Cleared Jun 25, 2008
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
K081395 · OVD
Biomet Spine
Orthopedic · 37d
Cleared Jun 25, 2008
XTAG RESPIRATORY VIRAL PANEL
K081483 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 28d
Cleared Jun 25, 2008
SENTINEL PLASMAPROTEINS CAL 3X
K081533 · JIX
SENTINEL CH. SpA
Chemistry · 23d
Cleared Jun 25, 2008
AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL...
K081612 · GEX
Aesculight, LLC
General & Plastic Surgery · 16d
Cleared Jun 25, 2008
CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL
K081634 · GEI
Conmed Corporation
General & Plastic Surgery · 14d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
K072140 · CFR
Alfa Wassermann Diagnostic...
Chemistry · 327d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
K072141 · CEO
Alfa Wassermann Diagnostic...
Chemistry · 327d
Cleared Jun 24, 2008
OSTAPEK VBR SYSTEM
K072326 · MQP
Co-Ligne AG
Orthopedic · 309d
Cleared Jun 24, 2008
S-TEST CA
K072356 · CJY
Alfa Wassermann Diagnostic...
Chemistry · 307d
Cleared Jun 24, 2008
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
K072861 · HJO
Acheve Technology, Inc.
Ophthalmic · 263d
Cleared Jun 24, 2008
MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
K073556 · HRS
Medxpert GmbH
Orthopedic · 188d
Cleared Jun 24, 2008
MODIFICATION TO GALILEO GOLD
K080181 · CBK
Hamilton Medical AG
Anesthesiology · 152d
Cleared Jun 24, 2008
PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
K080197 · GEI
Plasma Surgical, Ltd.
General & Plastic Surgery · 151d
Cleared Jun 24, 2008
ZURA TEE SYSTEM
K080223 · IYO
Imacor, LLC
Radiology · 147d