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
37825–37848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2014
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
K140588 · FXY
Stryker Corporation
General Hospital · 111d
Cleared Jun 26, 2014
COROENT THORACOLUMBAR IMPLANTS
K140659 · MAX
Nu Vasive, Incorporated
Orthopedic · 104d
Cleared Jun 26, 2014
LUNERAY
K140803 · JAQ
Nucletron B.V.
Radiology · 87d
Cleared Jun 26, 2014
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K141002 · HRX
Visionsense, Ltd.
Orthopedic · 69d
Cleared Jun 26, 2014
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
K141346 · LMC
Sony Electronics, Inc.
Radiology · 35d
Cleared Jun 26, 2014
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE...
K141376 · MNH
Nexxt Spine, LLC
Orthopedic · 30d
Cleared Jun 26, 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · MNI
Precision Spine, Inc.
Orthopedic · 29d
Cleared Jun 26, 2014
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
K141454 · LMC
Sony Electronics, Inc.
Radiology · 24d
Cleared Jun 25, 2014
ABSOLUTE DENTIN 2
K132115 · EBF
Parkell, Inc.
Dental · 351d
Cleared Jun 25, 2014
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
K132180 · NBW
Ideal Life, Inc.
Chemistry · 345d
Cleared Jun 25, 2014
BONDILOXS TOPICAL HEMOSTATIC DRESSING
K132333 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 334d
Cleared Jun 25, 2014
SATURNO(TM) OVERDENTURE IMPLANT SYSTEM
K133327 · DZE
Zest Anchors, LLC
Dental · 239d
Cleared Jun 25, 2014
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
K133848 · LNH
Heartvista, Inc.
Radiology · 189d
Cleared Jun 25, 2014
MASIMO ROOT MONITORING SYSTEM
K140188 · MWI
Masimo Corporation
Cardiovascular · 152d
Cleared Jun 25, 2014
OPTIMUS FUSION: SLT, YAG AND YAG/SLT
K140336 · HQF
Quantel Medical
Ophthalmic · 135d
Cleared Jun 25, 2014
VENUS SWAN(MP)2
K140629 · GEI
Venus Concept , Ltd.
General & Plastic Surgery · 106d
Cleared Jun 25, 2014
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
K140801 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 86d
Cleared Jun 25, 2014
TRUKLEAR BRACKET
K141104 · NJM
Ajw Technology Consultants, Inc.
Dental · 57d
Cleared Jun 24, 2014
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN...
K133083 · DBF
Diazyme Laboratories
Immunology · 267d
Cleared Jun 24, 2014
BREEZE NEBULIZER (NBR-10X)
K133105 · CAF
Digio2 International Co., Ltd.
Anesthesiology · 267d
Cleared Jun 24, 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
K133816 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 190d
Cleared Jun 24, 2014
MOBIUS3D
K140660 · IYE
Mobius Medical Systems, LP
Radiology · 102d
Cleared Jun 23, 2014
CONTOUR NEXT EZ BLOOD GLUCOSE METER
K130265 · NBW
Bayer Healthcare, LLC
Chemistry · 504d
Cleared Jun 23, 2014
NOVOPRESS
K131416 · JOW
Milka, LLC
Cardiovascular · 403d