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
31897–31920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2016
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K160496 · NLH
Innovative Health, LLC
Cardiovascular · 109d
Cleared Jun 10, 2016
BLUEPRINT Patient Specific Instrumentation
K160555 · KWS
Tornier S.A.S.
Orthopedic · 102d
Cleared Jun 10, 2016
ATTUNE Revision Knee System
K160700 · JWH
Depuy(Ireland)
Orthopedic · 88d
Cleared Jun 10, 2016
NeuroStar TMS Therapy System
K160703 · OBP
Neuronetics, Inc.
Neurology · 88d
Cleared Jun 10, 2016
Aequalis PerFORM+ Shoulder System
K160975 · KWS
Tornier, Inc.
Orthopedic · 64d
Cleared Jun 10, 2016
NEOVIEW Plating System
K160995 · HRS
In2bones Sas
Orthopedic · 63d
Cleared Jun 10, 2016
Arsenal Spinal Fixation System
K161363 · NKB
Alphatec Spine, Inc.
Orthopedic · 24d
Cleared Jun 09, 2016
Lucent Intervertebral Body Fusion Device
K152011 · MAX
Spinal Elements, Inc.
Orthopedic · 324d
Cleared Jun 09, 2016
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342 · GXR
St Jude Medical
Neurology · 295d
Cleared Jun 09, 2016
ATOVEN-Reusable Laser Fiber
K152667 · GEX
Diotech CO
General & Plastic Surgery · 266d
Cleared Jun 09, 2016
BSD4343 Digital Flat Panel X-ray Detector
K160204 · MQB
Bontech, Inc.
Radiology · 133d
Cleared Jun 09, 2016
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M...
K160370 · JGS
Shenzhen Mindray Bio-Medical...
Chemistry · 120d
Cleared Jun 09, 2016
MAKO 7
K160510 · HIH
Nvision Medical Corporation
Obstetrics & Gynecology · 106d
Cleared Jun 09, 2016
Masimo O3 Regional Oximeter System
K160526 · MUD
Masimo Corporation
Cardiovascular · 105d
Cleared Jun 09, 2016
3M Attest Rapid Readout Biological Indicator
K160546 · FRC
3M Company
General Hospital · 104d
Cleared Jun 09, 2016
Aquilion ONE (TSX-305A/3) V7.3
K160587 · JAK
Toshibamedical Systems Corporation
Radiology · 100d
Cleared Jun 09, 2016
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima...
K160618 · LNH
Ge Medical Systems, LLC
Radiology · 98d
Cleared Jun 09, 2016
NuVasive® Reline® System
K160989 · NKB
Nu Vasive, Incorporated
Orthopedic · 62d
Cleared Jun 09, 2016
MILAGRO ADVANCE PEEK Interference Screw
K161001 · MBI
Medos International SARL
Orthopedic · 59d
Cleared Jun 09, 2016
Oak Ridge Products Sharps Containers
K161180 · MMK
Oak Ridge Products, LLC
General Hospital · 43d
Cleared Jun 09, 2016
HEPATIQ 1.1
K161188 · LLZ
Hepatiq, LLC
Radiology · 43d
Cleared Jun 08, 2016
ProteXsure Safety Capsule System
K152597 · FMI
Starcap Medical, LLC ( Dba Prism...
General Hospital · 271d
Cleared Jun 08, 2016
MAIA
K153181 · MYC
Centervue S.P.A.
Ophthalmic · 218d
Cleared Jun 08, 2016
Miromatrix Biological Mesh
K160400 · OXH
Miromatrix Medical, Inc.
General & Plastic Surgery · 117d