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

LZA 2021-08-04

Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)

Applicant Hengchang (Dongying) Medical Technology Co., Ltd.

K-Number K211714

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PHX 2021-08-04

Tecomet Global Unite Short Stem Instrumentation

Applicant Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.

K-Number K211553

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FXX 2021-08-04

Disposable Surgical Face Mask

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K210643

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MBI 2021-08-04

Tigon Medical Button System

Applicant Tigon Medical

K-Number K211049

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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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