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

IYE 2021-11-02

TaiChiB

Applicant Our United Corporation

K-Number K210921

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OWY 2021-11-02

Tapestry Biointegrative Implant

Applicant Embody, Inc.

K-Number K212306

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DZE 2021-11-01

Alpha Dent Implants Dental Implants System

Applicant Alpha Dent Implants GmbH

K-Number K210499

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DXN 2021-11-01

Electronic Blood Pressure Monitor

Applicant Dongguan Kangweile Electronic Technology Co., Ltd.

K-Number K212171

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QQX 2021-11-01

BioFire COVID-19 Test 2

Applicant Biofire Defense, LLC

K-Number K211079

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MAX 2021-11-01

DePuy CONDUIT LLIF Angled Inserters

Applicant Enztec Limited

K-Number K212823

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FRG 2021-11-01

SterileRight sterilization pouch and roll

Applicant Sterileright Packaging Mfg., Inc.

K-Number K212338

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NGX 2021-11-01

Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K-Number K212948

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LZA 2021-11-01

Nitrile Examination Gloves (Blue, Violet)

Applicant Lyncmed Medical Technology (Beijing) Co., Ltd.

K-Number K211586

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LZA 2021-10-31

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Onetexx Sdn Bhd

K-Number K210588

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JCT 2021-10-30

Tracheal Stent System (Y-Shaped)

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K212403

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FLE 2021-10-29

Enbio S

Applicant Enbio Group AG

K-Number K210279

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