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

IPF 2021-12-14

TimeWaver Frequency

Applicant Timewaver Production GmbH

K-Number K212832

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FMI 2021-12-14

Blood Collection Needles

Applicant Vacutest Kima Srl

K-Number K200932

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MTC 2021-12-14

Instant 20s Indicator

Applicant True Indicating, LLC

K-Number K210481

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HRS 2021-12-13

CoLink NeoFuse Plating System

Applicant In2bones USA, LLC

K-Number K213069

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KPR 2021-12-13

Philips Radiology Smart Assistant

Applicant Philips Medical Systems Dmc GmbH

K-Number K212186

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HCI 2021-12-13

Aesculap Slim Clip Applier

Applicant Aesculap, Inc.

K-Number K211572

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NGX 2021-12-13

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)

Applicant Shenzhen Osto Technology Company Limited

K-Number K211942

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LZA 2021-12-13

Disposable Nitrile Powder-Free Examination Gloves

Applicant Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.

K-Number K213176

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FXX 2021-12-13

Surgical face mask: F-Y1-A

Applicant Jiande Chaomei Daily Chemicals Co., Ltd.

K-Number K202794

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DHA 2021-12-13

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

Applicant Diazyme Laboratories, Inc.

K-Number K212221

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FYA 2021-12-13

Disposable Surgical Gown

Applicant Henan Robestain Medical Products Co., Ltd.

K-Number K212925

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LFL 2021-12-13

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, Inc.

K-Number K212060

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