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 2021-11-05

Nitrile Examination Gloves

Applicant Anhui Fine Glove Medical Technology Co., Ltd.

K-Number K212551

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NFO 2021-11-05

Microcurrent device (Model: HBR2-1)

Applicant Shenzhen DJ Medical Equipment Co., Ltd.

K-Number K211055

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OVE 2021-11-05

Cervical Stand-Alone System

Applicant Eminent Spine, LLC

K-Number K212853

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LLZ 2021-11-05

Visible Patient Suite

Applicant Visible Patient, Sas

K-Number K212896

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OOK 2021-11-05

CoolSculpting Elite System

Applicant Zeltiq Aesthetics, Inc.

K-Number K212707

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IYN 2021-11-05

MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K212900

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LZA 2021-11-05

Disposable Nitrile Examination gloves

Applicant Fujian Yuanxin Safety Protection Technology Co., Ltd.

K-Number K212485

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FXX 2021-11-05

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))

Applicant Guangzhou Zhengkang Medical Equipment Co.,Ltd

K-Number K212460

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SBF 2021-11-05

NextAR Spine Platform

Applicant Medacta International S.A.

K-Number K210859

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IYO 2021-11-05

Acuson SC2000 Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K211726

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KTT 2021-11-05

TrueLok Evo

Applicant Orthofix Srl

K-Number K212044

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OBO 2021-11-05

Anterion

Applicant Heidelberg Engineering GmbH

K-Number K211817

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