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

HRX 2018-05-31

Single Use Arthroscopic Electrode (with Pencil)

Applicant Modern Medical Equipment Manufacturing Limited

K-Number K170703

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DSP 2018-05-31

CARDIOSAVE Intra-Aortic Balloon Pump

Applicant Datascope Corp.

K-Number K181122

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NAY 2018-05-31

EndoWrist 5mm Thoracic Grasper

Applicant Intuitive Surgical, Inc.

K-Number K173415

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NAY 2018-05-31

da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories

Applicant Intuitive Surgical, Inc.

K-Number K173906

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KOI 2018-05-31

ToFscan

Applicant Idmed

K-Number K172690

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MBI 2018-05-31

AEVUMED PHANTOM Suture Anchors

Applicant Aevumed, Inc.

K-Number K180464

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PHM 2018-05-31

ATEC Universal Spacer System

Applicant Alphatec Spine, Inc.

K-Number K180480

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CCK 2018-05-31

ETCO2 Sensor

Applicant Orantech, Inc.

K-Number K171828

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BTA 2018-05-31

SOMAVAC Device

Applicant Somavac Medical Solutions, Inc.

K-Number K180606

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HEB 2018-05-30

Playtex Stella Tampons

Applicant Playtex Manufacturing, Inc.

K-Number K180167

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DRN 2018-05-30

Pure Flow External Counter-Pulsation Device

Applicant Xtreem Pulse, LLC

K-Number K173483

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DRG 2018-05-30

ScioCardio ECG Transmitter

Applicant Synergen Technology Labs, LLC

K-Number K171019

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