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

FXX 2021-03-25

BRS Procedure Face Mask

Applicant Blackbriar Regulatory Services, LLC

K-Number K202824

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GZB 2021-03-25

Nalu Neurostimulation System

Applicant Boston Scientific Neuromodulation

K-Number K203547

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IYO 2021-03-25

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

Applicant Echosens

K-Number K203273

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POM 2021-03-25

ANAM Test System

Applicant Vista Lifesciences, Inc.

K-Number K201376

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HRS 2021-03-25

Arthrex Patella SuturePlates

Applicant Arthrex, Inc.

K-Number K203834

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FXX 2021-03-25

Disposable Medical Mask

Applicant Hangzhou Qianzhiya Sanitary Products Co., Ltd.

K-Number K202133

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IRP 2021-03-25

Air compression therapy system FO-3001; Air compression therapy system FO-3008

Applicant Foshan Hongfeng Co., Ltd.

K-Number K201982

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MBI 2021-03-24

Betta Link Knotless Implant System

Applicant T.A.G. Medical Products Corporation, Ltd.

K-Number K210498

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KNT 2021-03-24

ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube

Applicant Envizion Medical , Ltd.

K-Number K203133

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MQB 2021-03-24

I-Q View

Applicant First Source, Inc.

K-Number K203703

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FPA 2021-03-24

Safety Subcutaneous Infusion Set

Applicant Epic Medical Pte. , Ltd.

K-Number K201626

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LZA 2021-03-24

Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color

Applicant Shen Wei USA, Inc.

K-Number K202080

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