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

LNH 2019-01-11

uMR 580, uMR 588

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K183137

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NVP 2019-01-11

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)

Applicant Trudell Medical International

K-Number K181649

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JDR 2019-01-11

Geo Staple System

Applicant Gramercy Extremity Orthopedics, LLC

K-Number K182212

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NAY 2019-01-11

Senhance Ultrasonic System

Applicant Transenterix, Inc.

K-Number K182421

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OMP 2019-01-11

Applied Tissue Technologies PWD Platform Wound Dressing

Applicant Applied Tissue Technologies, LLC

K-Number K182409

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HWC 2019-01-11

PROSTEP MICA Screw System

Applicant Wrightmedicaltechnologyinc

K-Number K181377

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KPR 2019-01-11

MULTIX Impact

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K182517

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NUV 2019-01-11

ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)

Applicant I-Tech Industries Srl

K-Number K182453

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MAX 2019-01-11

II-Type Intervertebral Spacer

Applicant Paonan Biotech Co., Ltd.

K-Number K180228

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JWY 2019-01-11

MTS Tetracycline 0.016 - 256 ug/mL

Applicant Liofilchem s.r.l.

K-Number K183140

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JWY 2019-01-11

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

Applicant Biomerieux S.A.

K-Number K183031

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FPA 2019-01-11

Tamper Evident Cap with Male Luer Lock

Applicant International Medical Industries, Inc.

K-Number K182545

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