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

IRP 2020-02-28

Therm-X

Applicant Zenith Technical Innovations

K-Number K193550

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JKA 2020-02-28

Steripath Gen2 Blood Collection System

Applicant Magnolia Medical Technologies, Inc.

K-Number K192247

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LNH 2020-02-28

Magnetom Sola, Magnetom Altea and Magnetom Sola Fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192496

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OWN 2020-02-28

Cellvizio I.V.E. with Confocal Miniprobes

Applicant Mauna Kea Technologies

K-Number K193416

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JDO 2020-02-28

CONQUEST FN

Applicant Smith & Nephew, Inc.

K-Number K193029

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LZO 2020-02-28

Zimmer M/L Taper Hip Prosthesis

Applicant Zimmer, Inc.

K-Number K192660

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IYE 2020-02-28

Alta Multipurpose Device

Applicant Qfix

K-Number K193243

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MUH 2020-02-28

R-Sensor, R-Sensor

Applicant Remedi Co., Ltd.

K-Number K200284

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OVE 2020-02-28

Atlas Spine Expandable Cervical Standalone Interbody System

Applicant Atlas Spine, Inc.

K-Number K192570

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JAQ 2020-02-28

CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor

Applicant Mick Radio-Nuclear Instruments, Inc.

K-Number K200221

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DWJ 2020-02-28

Arctic Sun Stat Temperature Management System

Applicant Medivance, Inc.

K-Number K200225

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QKB 2020-02-28

AccuContour

Applicant Xiamen Manteia Technology , Ltd.

K-Number K191928

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