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
60721–60744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2006
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR
K062652 · MNW
Tanita Corporation of America
Gastroenterology & Urology · 112d
Cleared Dec 28, 2006
COLLIMATOR, MODEL M-38
K062788 · KPW
Umi International
Radiology · 101d
Cleared Dec 28, 2006
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1,...
K063164 · LDJ
Ortho-Clinical Diagnostics, Inc.
Toxicology · 71d
Cleared Dec 28, 2006
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · LPS
Dade Behring, Inc.
Chemistry · 66d
Cleared Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
K063276 · JIL
Bayer Healthcare, LLC
Chemistry · 59d
Cleared Dec 27, 2006
RIGIDOMETER, MODEL DIR-4U
K061676 · LIL
Uroan 21
Gastroenterology & Urology · 196d
Cleared Dec 27, 2006
CARBON DIOXIDE MONITOR, MODEL OLG-2800A
K062115 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 156d
Cleared Dec 27, 2006
ENA CEM
K062355 · EMA
Micerium S.P.A.
Dental · 135d
Cleared Dec 27, 2006
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
K062555 · NBW
Visgeneer, Inc.
Chemistry · 119d
Cleared Dec 27, 2006
FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)
K063009 · HRS
Praesidia S.R.L.
Orthopedic · 86d
Cleared Dec 27, 2006
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017 · JDQ
Aesculap, Inc.
Orthopedic · 86d
Cleared Dec 27, 2006
CANDELA 3630 LASER SYSTEM
K063074 · GEX
Candela Corp.
General & Plastic Surgery · 82d
Cleared Dec 27, 2006
METAIZEAU NAILING SYSTEM
K063225 · HSB
Howmedica Osteonics Corp.
Orthopedic · 64d
Cleared Dec 27, 2006
ARC SURGICAL BONE REDUCTION SCREW
K063244 · HWC
Arc Surgical, LLC
Orthopedic · 62d
Cleared Dec 27, 2006
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT...
K063643 · LCP
Bio-Rad Laboratories Inc., Clinical...
Chemistry · 20d
Cleared Dec 26, 2006
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
K060416 · MQP
Ulrich GmbH & Co. KG
Orthopedic · 312d
Cleared Dec 26, 2006
MOONCUP
K060852 · HHE
Mooncup Limited
Obstetrics & Gynecology · 273d
Cleared Dec 26, 2006
SSP VERTEBRAL BODY REPLACEMENT
K061578 · MQP
Specialty Spine Products, LLC
Orthopedic · 202d
Cleared Dec 26, 2006
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
K062265 · IZQ
Swiss Medical Care S.A.
Radiology · 144d
Cleared Dec 26, 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583 · MVM
Phadia US, Inc.
Immunology · 116d
Cleared Dec 26, 2006
LTD POLYAXIAL FIXATION SYSTEM
K062785 · KWP
Us Spine
Orthopedic · 99d
Cleared Dec 26, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
K062924 · NQD
Dade Behring, Inc.
Chemistry · 89d
Cleared Dec 26, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
K063143 · LFX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 71d
Cleared Dec 26, 2006
AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K063262 · IZL
Virtual Imaging
Radiology · 57d