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

JOW 2016-07-13

ActiveCare Home

Applicant Medical Compression Systems (Dbn) , Ltd.

K-Number K160431

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LLZ 2016-07-13

Multi Modality Viewer

Applicant Vital Images, Inc.

K-Number K161419

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EBZ 2016-07-13

VALO Grand

Applicant Ultradent Products, Inc.

K-Number K160551

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MUW 2016-07-13

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

Applicant Contamac, Ltd.

K-Number K160859

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LPL 2016-07-13

PolyDev Soft Contact Lenses

Applicant Polydev , Ltd.

K-Number K160977

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LPL 2016-07-13

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens

Applicant CooperVision, Inc.

K-Number K160803

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BSO 2016-07-13

E-Cath

Applicant PAJUNK GmbH Medizintechnologie

K-Number K152952

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IYN 2016-07-13

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K161525

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LHN 2016-07-13

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

Applicant Hitachi , Ltd.

K-Number K161163

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FMF 2016-07-12

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

Applicant Sung Shim Medicare Co., Ltd.

K-Number K152803

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PBX 2016-07-12

InMode Plus System

Applicant Inmode MD , Ltd.

K-Number K153568

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EBF 2016-07-12

Gradia Plus

Applicant GC America, Inc.

K-Number K153325

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