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

FZP 2020-09-02

Aesculap PAS-Port Proximal Anastomosis System

Applicant Aesculap, Inc.

K-Number K202124

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MLO 2020-09-02

RX-1 Rhythm Express Remote Cardiac Monitoring System

Applicant VivaQuant, Inc.

K-Number K200833

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QMI 2020-09-02

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

Applicant Roche Molecular Systems, Inc.

K-Number K202215

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EBG 2020-09-02

Bright Temporary C&B

Applicant Dmp Dental Industry S.A.

K-Number K192830

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IYN 2020-09-02

EPIQ Series Diagnostic Ultrasound Systems

Applicant Philips Ultrasound, Inc.

K-Number K202216

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OBO 2020-09-02

OCT-Camera ID 21101A3

Applicant Optomedical Technologies GmbH

K-Number K200516

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HRS 2020-09-02

Arthrex Mesh Plates

Applicant Arthrex, Inc.

K-Number K201677

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LFD 2020-09-02

Oral-B Dry Mouth Oral Rinse

Applicant The Procter & Gamble Company

K-Number K201277

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FDS 2020-09-02

Endofresh Digestive Endoscopy System

Applicant Huizhou Xzing Technology Co., Ltd.

K-Number K192704

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KLE 2020-09-02

EtchPro Etching Gel

Applicant Belport Company, Inc., Gingi-Pak

K-Number K200462

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MBI 2020-09-02

ATL Anchors

Applicant International Life Sciences

K-Number K200503

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NDP 2020-09-02

Simplant Digital Guide

Applicant Dentsply Sirona

K-Number K193405

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