Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

KGN 2019-01-17

ProgenaMatrix

Applicant Cell Constructs I, LLC

K-Number K182010

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CBK 2019-01-17

Savina 300

Applicant Dragerwerk AG & CO Kgaa

K-Number K180779

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GEI 2019-01-17

VIVA combo RF System

Applicant Starmed Co., Ltd.

K-Number K183538

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OLZ 2019-01-17

Esprit Nova

Applicant Neurozone Msh Incorporated

K-Number K182227

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KWQ 2019-01-17

Pinehurst Anterior Cervical Plate System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K181190

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HSX 2019-01-17

Bodycad Unicompartmental Knee System

Applicant Bodycad Laboratories, Inc.

K-Number K181302

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DXH 2019-01-17

Study Watch

Applicant Verily Life Sciences, LLC

K-Number K182456

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LZA 2019-01-16

Powder Free Nitrile Patient Examination Gloves, Blue Color

Applicant Jiangsu Dongxin Medical Technology Co., Ltd.

K-Number K181106

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HRX 2019-01-16

Pristine Scope

Applicant Pristine Surgical

K-Number K183165

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HSB 2019-01-16

Estremo Citieffe Nailing System

Applicant Citieffe S.R.L.

K-Number K181540

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MQB 2019-01-16

Carestream DRX-1 System with DRX Core Detectors

Applicant Carestream Health, Inc.

K-Number K183474

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KWQ 2019-01-16

4CIS® Pinehurst Anterior Cervical Plate system

Applicant Solco Biomedical Co., Ltd.

K-Number K182489

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