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

IYN 2017-03-23

DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System

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

K-Number K170277

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NDC 2017-03-22

My Dose Coach

Applicant Sanofi, Inc.

K-Number K163099

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DQX 2017-03-22

Fathom-16 Steerable Guidewires

Applicant Boston Scientific Corporation

K-Number K170636

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PNR 2017-03-22

ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT

Applicant Pentaferte Italia S.R.L.

K-Number K161141

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LZC 2017-03-22

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

Applicant Gmp Medicare Sdn. Bhd.

K-Number K163017

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PNR 2017-03-22

ENFit enteral syringe

Applicant Jiangyin Caina Technology Co., Ltd.

K-Number K161979

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CBF 2017-03-22

OxyHeal 4000 Multiplace Hyperbaric Chamber Family

Applicant Oxyheal Medical Systems, Inc.

K-Number K163109

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CAH 2017-03-22

ThermoShield HME Filter

Applicant Flexicare Medical Limited.

K-Number K163300

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KWQ 2017-03-22

Butrex Lumbar Buttress Plating System

Applicant X-Spine Systems, Inc.

K-Number K170530

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MLZ 2017-03-22

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+

Applicant Alcon Research, Ltd.

K-Number K170520

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HKY 2017-03-21

Icare HOME tonometer

Applicant Icare Finland OY

K-Number K163343

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LJL 2017-03-21

Nix Ultra Lice Treatment Kit

Applicant Medtech Products, Inc.

K-Number K163401

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