Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

JAK 2016-08-24

SOMATOM Drive

Applicant Siemens Medical Solutions USA, Inc.

K-Number K161196

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NDN 2016-08-24

Kyphon HV-R Bone Cement

Applicant Medtronic, Inc.

K-Number K160983

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MAX 2016-08-24

XYcor® Expandable Spinal Spacer System

Applicant Alphatec Spine, Inc.

K-Number K160646

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FLL 2016-08-24

Infrared Forehead Thermometer, FT-100A

Applicant Hangzhou Universal Electronic Co., Ltd.

K-Number K160802

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LLZ 2016-08-24

ResolutionMD

Applicant Calgary Scientific, Inc.

K-Number K161130

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PND 2016-08-24

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K-Number K161313

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KWQ 2016-08-23

ZION Anterior Cervical Fixation System

Applicant Astura Medical

K-Number K160702

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KLW 2016-08-23

HyperSound Tinnitus Module

Applicant Turtle Beach Corporation

K-Number K161331

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GEH 2016-08-23

Accurett

Applicant H&O Equipments, Nv/Sa

K-Number K161615

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EBF 2016-08-23

KATANA AVENCIA Block

Applicant Kuraray Noritake Dental, Inc.

K-Number K153476

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OOD 2016-08-23

GalaSHAPE 3D

Applicant Tepha, Inc.

K-Number K161092

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LNH 2016-08-23

Vantage Titan 1.5T, MRT-1510, V3.6 Software

Applicant Toshibamedical Systems Corporation

K-Number K160632

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