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

HKX 2019-12-06

Intraocular Pressure Tonometer EASYTON

Applicant Company Elamed

K-Number K190382

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GWG 2019-12-06

Aurora Surgiscope System

Applicant Rebound Therapeutics

K-Number K191861

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BZH 2019-12-06

Smart Peak Flow Meter

Applicant Guangzhou Homesun Medical Technology Co., Ltd.

K-Number K191239

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ONF 2019-12-06

Intense Pulsed Light Treatment System

Applicant Shangdong Huamei Technology Co., Ltd.

K-Number K192521

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LPH 2019-12-05

G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene

Applicant Zimmer, Inc.

K-Number K190660

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GEI 2019-12-05

BTL-899

Applicant Btl

K-Number K192224

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QJG 2019-12-05

TOMi Scope

Applicant Photonicare, Inc.

K-Number K191804

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QIV 2019-12-05

cobas vivoDx MRSA

Applicant Roche Molecular Systems, Inc.

K-Number DEN190016

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NHA 2019-12-05

Southern Implants PEEK Abutments

Applicant Southern Implants (Pty), Ltd.

K-Number K191250

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HSX 2019-12-05

BC Reflex Uni Knee System

Applicant Bodycad Laboratories, Inc.

K-Number K191996

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MUH 2019-12-05

Digital Intraoral Imaging Plate System

Applicant Fsusen Technology Co., Ltd.

K-Number K192766

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DXT 2019-12-05

MEDRAD Mark 7 Arterion Injection System

Applicant Bayer Medical Care, Inc.

K-Number K193028

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