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

FXX 2021-05-14

Disposable Medical mask

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K-Number K210302

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GEI 2021-05-14

MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Applicant Integra Microfrance

K-Number K210942

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LYZ 2021-05-14

Powder Free Vinyl Patient Examination Gloves

Applicant Yunnan Huazhiyuan Medical Technology Co., Ltd.

K-Number K210799

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DZE 2021-05-14

BoneTrust Mini Implant System

Applicant Medical Instinct Deutschland GmbH

K-Number K200573

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FXX 2021-05-13

United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask

Applicant United Sewing Automation, Inc.

K-Number K202697

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IYN 2021-05-13

HS40 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K210426

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FXX 2021-05-13

Disposable Face Mask

Applicant Biobase Scientific (Shandong) Co., Ltd.

K-Number K210815

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GEH 2021-05-13

CryoVIVE

Applicant Recensmedical, Inc.

K-Number K203481

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JWH 2021-05-13

LinkSymphoKnee System

Applicant Waldemar Link GmbH & Co. KG

K-Number K202924

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LNH 2021-05-13

SIGNA 7.0T

Applicant Ge Medical Systems, LLC

K-Number K211118

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JWH 2021-05-13

GMK Spherika Femurs and Fixed Tibial Trays Plus

Applicant Medacta International S.A.

K-Number K211004

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IPF 2021-05-13

Prelivia

Applicant Rehabtronics, Inc.

K-Number K210979

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