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

DYH 2019-03-01

BrackFix

Applicant Voco GmbH

K-Number K183147

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IRP 2019-03-01

Polar Care Wave

Applicant Breg, Inc.

K-Number K183702

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HWC 2019-03-01

CurvaFix Intramedullary Rodscrew System

Applicant Curvafix, Inc.

K-Number K180050

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DQA 2019-03-01

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

Applicant Taiwan Aulisa Medical Devices Technologies, Inc.

K-Number K183067

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MVM 2019-02-28

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

Applicant Euroimmun Us, Inc.

K-Number K183313

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FLL 2019-02-28

Digital Thermometer

Applicant Joytech Healthcare Co. , Ltd.

K-Number K182629

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DSB 2019-02-28

ReDS System

Applicant Sensible Medical Innovations , Ltd.

K-Number K180479

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NEY 2019-02-28

Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)

Applicant AngioDynamics, Inc.

K-Number K182250

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DQK 2019-02-28

QUANTIEN Measurement System

Applicant St. Jude Medical (Now Abbott Medical)

K-Number K183099

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DTE 2019-02-28

Lifetech Cardio Model 8301 Temporary Pacemaker

Applicant Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

K-Number K182839

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FDS 2019-02-28

FUJIFILM Endoscope Model EG-530N

Applicant Fujifilm Corporation

K-Number K183686

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KTT 2019-02-28

Austin Miller Large External Fixation System

Applicant Austin Miller Trauma, LLC

K-Number K181528

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