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
56401–56424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2008
RESICEM
K080517 · EMA
Shofu Dental Corp.
Dental · 107d
Cleared Jun 11, 2008
DESKTOP PRO
K080585 · IYE
Elekta , Ltd.
Radiology · 100d
Cleared Jun 11, 2008
SATURN 9000-810
K080589 · MQB
New Medical Co., Ltd.
Radiology · 100d
Cleared Jun 11, 2008
GC OPB-100
K080724 · DYH
GC America, Inc.
Dental · 89d
Cleared Jun 11, 2008
VINTAGE ART
K080834 · EIH
Shofu Dental Corp.
Dental · 78d
Cleared Jun 11, 2008
CURE CATHETER CLOSED SYSTEM
K080881 · KOD
Cure Medical, LLC
Gastroenterology & Urology · 72d
Cleared Jun 11, 2008
MODEIFICATION TO IPLAN RT DOSE
K080888 · MUJ
Brainlab AG
Radiology · 72d
Cleared Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · LLH
bioMerieux, Inc.
Microbiology · 70d
Cleared Jun 11, 2008
USHIFU STEPPER
K080970 · ITX
Ushifu Development Company, LLC
Radiology · 68d
Cleared Jun 11, 2008
PRECISION 500D R&F X-RAY SYSTEM
K081091 · JAA
Ge Healthcare
Radiology · 56d
Cleared Jun 11, 2008
21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
K081242 · LLZ
Tokotu Electric Co., Ltd.
Radiology · 41d
Cleared Jun 11, 2008
VERTEX RECONSTRUCTION SYSTEM
K081297 · KWP
Medtronic Sofamor Danek
Orthopedic · 35d
Cleared Jun 11, 2008
ALZ WEB PACS, VERSION 1.0
K081304 · LLZ
Alz, Inc.
Radiology · 34d
Cleared Jun 11, 2008
MODIFICATION TO INREACH SYSTEM
K081379 · JAK
Superdimension, Ltd.
Radiology · 26d
Cleared Jun 11, 2008
BROWNE OPA TEST STRIP
K081427 · JOJ
STERIS Corporation
General Hospital · 21d
Cleared Jun 11, 2008
CSBP-001A BODY ORGAN PERFUSION SYSTEM
K081482 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 10, 2008
MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
K080550 · ODB
Minos Medical
Gastroenterology & Urology · 103d
Cleared Jun 10, 2008
INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
K080673 · MAX
Vertebral Technologies, Inc.
Orthopedic · 92d
Cleared Jun 10, 2008
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K080755 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 85d
Cleared Jun 10, 2008
KYMCO FORU, MODEL EQ40
K081133 · INI
Kwang Yang Motor Co., Ltd.
Physical Medicine · 50d
Cleared Jun 10, 2008
T2 FEMORAL NAIL
K081152 · HSB
Howmedica Osteonics Corp.
Orthopedic · 48d
Cleared Jun 10, 2008
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
K081332 · MQP
Signus Medizintechnik GmbH
Orthopedic · 29d
Cleared Jun 09, 2008
SL-PLUS STANDARD AND LATERAL HIP STEMS
K072852 · LZO
Smith & Nephew, Inc.
Orthopedic · 249d
Cleared Jun 09, 2008
HE4 EIA, MODEL: 404-10 US
K072939 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 236d