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

FRO 2021-02-05

Antibacterial Bandage

Applicant Jiangsu Excellence Medical Supplies Co., Ltd.

K-Number K201324

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DSA 2021-02-05

Patient Monitoring Cables

Applicant Jkh USA, LLC

K-Number K203635

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EBF 2021-02-05

Shofu Block HC Hard

Applicant Shofu Dental Corporation

K-Number K200470

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FXX 2021-02-04

Medical Face Mask

Applicant Gemtier Medical (Shanghai), Inc.

K-Number K202493

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NGX 2021-02-04

BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set

Applicant Bemer Int AG

K-Number K210174

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LLZ 2021-02-04

QUIBIM Precision Prostate (qp-Prostate)

Applicant Quibim S.L.

K-Number K203582

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ODP 2021-02-04

Prase PEEK Anterior Cervical Interbody Spacer

Applicant Gbs Commonwealth Co., Ltd.

K-Number K202872

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OLO 2021-02-04

RESPONSE Navigation Instruments

Applicant OrthoPediatrics Corp.

K-Number K203573

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FXX 2021-02-03

Medical Face Masks

Applicant Guilin Hbm Sanitary Protections, Inc.

K-Number K202627

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HRS 2021-02-03

Arthrex Pilon Fusion System

Applicant Arthrex, Inc.

K-Number K203294

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GXY 2021-02-03

Jiajian Self-Adhesive Electrode

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K-Number K192568

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PHQ 2021-02-03

UNiTi ACDF Implant System

Applicant Pressio, Inc.

K-Number K200301

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