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

NQQ 2021-06-08

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Applicant ABBOTT MEDICAL

K-Number K210458

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FXX 2021-06-08

Medical Face Mask

Applicant Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.

K-Number K211062

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FXX 2021-06-07

Disposable Surgical Mask

Applicant Dongguan Shin YI Healthcare Products Factory

K-Number K210372

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MBI 2021-06-07

Suture Wing

Applicant Osteonic Co., Ltd.

K-Number K202663

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MAX 2021-06-07

X-Pac Expandable Lumbar Cage System

Applicant Expanding Innovations, Inc.

K-Number K203802

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DXN 2021-06-07

HRVWatch-Mini Wrist Monitor

Applicant Taiwan Scientific Corporation

K-Number K201914

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FXX 2021-06-07

Disposable Medical Mask

Applicant Tuosheng Protective Products (Ningbo) Co., Ltd.

K-Number K210641

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MVA 2021-06-07

SnugKap

Applicant Headstart, Ltd.

K-Number K193383

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FXX 2021-06-07

Disposable Surgical Mask

Applicant Qingdao Likangyuan Medical Device Co., Ltd.

K-Number K202580

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KWS 2021-06-07

Augmented VaultLock Glenoid

Applicant Arthrex, Inc.

K-Number K210050

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FXX 2021-06-07

Surgical Face Mask (Ear loops and Tie-on)

Applicant Wuhan Dymex Healthcare Co., Ltd.

K-Number K210433

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NDC 2021-06-04

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K-Number K202596

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