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

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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FLE 2018-05-30

MN-111

Applicant W&H Sterilization S.R.L.

K-Number K172825

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LPH 2018-05-30

Legend Acetabular Liners

Applicant Ortho Development Corporation

K-Number K173951

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MYC 2018-05-30

Retia 2

Applicant Centervue S.P.A.

K-Number K180293

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MAI 2018-05-30

MICRORAPTOR REGENESORB Suture Anchor

Applicant Smith and Nephew, Inc.

K-Number K180361

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MBI 2018-05-30

KATOR Suture Anchor

Applicant Kator, LLC

K-Number K173269

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NKB 2018-05-30

EVEREST Spinal System

Applicant K2m, Inc.

K-Number K181188

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DXQ 2018-05-30

ANEROID SPHYGMOMANOMETER

Applicant Wenzhou Bokang Instruments Co., Ltd.

K-Number K173246

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