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

LLZ 2021-11-02

VisionX 3.0

Applicant Durr Dental SE

K-Number K213326

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EMA 2021-11-02

Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)

Applicant Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K-Number K210473

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PIF 2021-11-02

Pediatric Nasogastric Feeding Tubes - Single ENFit Port

Applicant Cair Lgl

K-Number K210598

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LZA 2021-11-02

Powder Free Nitrile Patient Examination Gloves, Blue Color

Applicant Shandong Jieshi Medical Products Co., Ltd.

K-Number K210777

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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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