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
60625–60648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2007
NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1
K063539 · LLZ
Nordicicemedical AS
Radiology · 54d
Cleared Jan 17, 2007
3 SERIES PHOTOTHERAPY CABINET
K063621 · FTC
Daavlin Co.
General & Plastic Surgery · 43d
Cleared Jan 17, 2007
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
K063653 · HCG
Micrus Endovascular Corporation
Neurology · 40d
Cleared Jan 17, 2007
FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
K063736 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 30d
Cleared Jan 17, 2007
SEPRAMESH, MODEL 5959-1214
K063739 · FTL
Genzyme Corporation
General & Plastic Surgery · 30d
Cleared Jan 17, 2007
EXPEDIUM SPINE SYSTEM
K063741 · NKB
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Jan 17, 2007
COBAS INTEGRA C 111
K063744 · CIG
Rochdiag
Chemistry · 30d
Cleared Jan 16, 2007
C-JAWS CERVICAL COMPRESSIVE MINI FRAME
K062181 · KWP
Medicrea Technologies
Orthopedic · 169d
Cleared Jan 16, 2007
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
K062775 · LPH
Ortho Development Corp.
Orthopedic · 120d
Cleared Jan 16, 2007
U2 HIP STEM, TI PLASMA SPRAY
K062978 · LWJ
United Orthopedic Corp.
Orthopedic · 109d
Cleared Jan 16, 2007
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
K063688 · HWE
The Anspach Effort, Inc.
Orthopedic · 35d
Cleared Jan 12, 2007
LOCOBASE WOUND AND SKIN EMULSION
K060272 · FRO
Ferndale Laboratories, Inc.
General & Plastic Surgery · 344d
Cleared Jan 12, 2007
SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
K061430 · FEB
Custom Ultrasonics
General Hospital · 234d
Cleared Jan 12, 2007
EASYGLUCO, MODEL IGM-0002 G2
K061431 · CGA
U. S. Diagnostics, Inc.
Chemistry · 233d
Cleared Jan 12, 2007
PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20,...
K061678 · DRF
Prorhythm
Cardiovascular · 211d
Cleared Jan 12, 2007
VERTIFLEX SPINAL SCREW SYSTEM
K062670 · MNH
Vertiflex (Tm), Incorporated
Orthopedic · 127d
Cleared Jan 12, 2007
PARAMOUNT VBR SYSTEM
K062759 · MQP
Innovative Spinal Technologies, Inc.
Orthopedic · 119d
Cleared Jan 12, 2007
CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/...
K062800 · NBW
Taidoc Technology Corporation
Chemistry · 115d
Cleared Jan 12, 2007
PAJUNKS STIMULONG TSUI-METHOD SET
K062900 · CAZ
PAJUNK GmbH Medizintechnologie
Anesthesiology · 107d
Cleared Jan 12, 2007
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
K062966 · ORH
Seradyn, Inc.
Chemistry · 105d
Cleared Jan 12, 2007
DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
K062996 · GXZ
Axon Systems, Inc.
Neurology · 102d
Cleared Jan 12, 2007
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
K063052 · JEY
Walter Lorenz Surgical, Inc.
Dental · 100d
Cleared Jan 12, 2007
TENDER FIBER
K063170 · EBI
Micerium S.P.A.
Dental · 86d
Cleared Jan 12, 2007
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
K063217 · DTK
B.Braun Medical, Inc.
Cardiovascular · 80d