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

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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FIZ 2020-09-02

SmartHDM-510 System

Applicant Mesa Laboratories, Inc.

K-Number K201765

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IYT 2020-09-01

Patient Administration Set

Applicant Cyclomedica Australia Pty, Ltd.

K-Number K200916

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FEB 2020-09-01

Endoscope Reprocessor OER-Elite

Applicant Olympus Medical Systems Corp.

K-Number K201920

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FET 2020-09-01

Image1 S CCU, Image1 S 4U Camera Head

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K201135

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IYN 2020-09-01

Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K202160

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PKL 2020-09-01

Resolution 360™ ULTRA Clip

Applicant Boston Scientific Corporation

K-Number K193424

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OAP 2020-09-01

CAPOGEN Laser Cap

Applicant Nature, Inc.redible, Inc.

K-Number K201854

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