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

PHX 2019-12-02

Integra TITAN Reverse Shoulder System

Applicant Integra LifeSciences Corporation

K-Number K190588

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NUH 2019-12-02

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

Applicant Hong Qiangxing (Shenzhen) Electronics Limited

K-Number K190009

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FXX 2019-12-02

Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip

Applicant Cardinal Health200, LLC

K-Number K192374

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OLO 2019-12-02

Vital Navigation System

Applicant Zimmer Biomet Spine, Inc.

K-Number K191722

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LHI 2019-12-02

Decanting Device

Applicant Gcmedica Enterprise Ltd.(Wuxi)

K-Number K182819

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LOD 2019-12-02

Hi-Fatigue Bone Cement

Applicant Osartis GmbH

K-Number K192394

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DQA 2019-12-02

Checkme O2 Pulse Oximeter

Applicant Shenzhen Viatom Technology Co., Ltd.

K-Number K191088

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QFA 2019-12-02

WOUNDCHEK Bacterial Status

Applicant Alere Scarborough, Inc.

K-Number DEN180014

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LLZ 2019-12-02

Emprint Visualization Application

Applicant Covidien, LLC

K-Number K192038

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KLE 2019-12-02

Zipbond

Applicant Sdi Limited

K-Number K191656

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FMK 2019-12-02

Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K192666

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QSY 2019-12-02

NasalCEASE and BleedCEASE

Applicant Les Laboratoires Brothier S.A.

K-Number K183622

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