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

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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PHX 2021-11-04

Comprehensive® Convertible Glenoid - Vivacit-E Liner

Applicant Biomet Manufacturing Corp

K-Number K211729

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MAI 2021-11-04

OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

Applicant B-One Ortho, Corp.

K-Number K212912

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CBK 2021-11-04

CARESCAPE R860

Applicant Datex-Ohmeda, Inc.

K-Number K210384

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OHT 2021-11-04

IPL Hair Removal Device, model: AI01

Applicant Shenzhen Century Dongyuan Technology CO , Ltd.

K-Number K212897

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DXN 2021-11-04

Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B

Applicant Microlife Intellectual Property GmbH

K-Number K211288

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LZA 2021-11-04

Disposable Nitrile Examination Glove

Applicant Inner Mongolia Boming Medical Supplies Co., Ltd.

K-Number K212467

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FXX 2021-11-04

Medical Face Mask

Applicant Haian Medigauze Co., Ltd.

K-Number K212471

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