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

FOZ 2021-10-25

Introcan Safety 3 Closed IV Catheter

Applicant B.Braun Medical, Inc.

K-Number K213085

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FXX 2021-10-25

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)

Applicant Jiangmen Ningrui Medical Supplies Co., Ltd.

K-Number K212293

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FXX 2021-10-24

Surgical Face Mask

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K212368

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FXX 2021-10-24

Disposable Medical Surgical Mask

Applicant Weihai Dishang Medical Technology Co., Ltd.

K-Number K210348

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LYZ 2021-10-24

Vinyl Examination Gloves(Yellow)

Applicant Liuping Trading Co., Ltd.

K-Number K211698

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FYA 2021-10-24

Surgical Gown

Applicant Hubei Wanli Protective Products Co., Ltd.

K-Number K211509

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HEB 2021-10-22

Cohitech Organic Cotton Non-Applicator Cottonlock Tampons

Applicant Cotton High Tech S.L.

K-Number K211775

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GEH 2021-10-22

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit

Applicant Nuance Medical, LLC

K-Number K210310

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FRG 2021-10-22

Tyvek(R) Roll with CI for STERLINKTM Sterilizer

Applicant Plasmapp Co,., Ltd.

K-Number K212198

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GEX 2021-10-22

CO2 Laser Machine, Model: BW-203B

Applicant Zhengzhou Bestview ST Co., Ltd.

K-Number K211735

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GEI 2021-10-22

Neuromark System

Applicant Neurent Medical

K-Number K212666

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FRC 2021-10-22

Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K-Number K212193

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