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

LCX 2021-08-04

Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)

Applicant Atlas Link Technology Co., Ltd.

K-Number K203246

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MBI 2021-08-04

Alpha Vent PEEK Suture Anchor

Applicant Stryker Endoscopy

K-Number K211502

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OPC 2021-08-03

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K211758

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IZL 2021-08-03

Remex KA6

Applicant Remedi Co., Ltd.

K-Number K212144

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KGO 2021-08-03

ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs

Applicant Careplus (M) Sdn Bhd

K-Number K210724

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LIT 2021-08-03

PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)

Applicant Qualimed USA, LLC

K-Number K201246

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GEI 2021-08-03

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

Applicant Venclose, Inc.

K-Number K211806

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FAS 2021-08-03

Resection Electrodes with HF cable

Applicant Olympus Winter & Ibe GmbH

K-Number K210651

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FXX 2021-08-03

Surgical Face Mask

Applicant Zhejiang Hongyu Medicali Commodity Co., Ltd.

K-Number K211897

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HWC 2021-08-03

Cannulated Fasteners and Nuts

Applicant OsteoCentric Technologies

K-Number K211290

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PEM 2021-08-03

Minitube Dentasleeve Protective Barrier Sleeves

Applicant Minitube AB

K-Number K211026

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CHL 2021-08-02

OPTI® B-Lac Cassette

Applicant Opti Medical Systems, Inc.

K-Number K200986

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