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

EBF 2021-02-03

Omnichroma Flow Bulk

Applicant Tokuyama Dental Corporation

K-Number K203598

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HRX 2021-02-03

Balex bone Expander System

Applicant Taeyeon Medical Co., Ltd.

K-Number K202027

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LZO 2021-02-03

EcoFit® Hip System

Applicant Implantcast GmbH

K-Number K203420

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QHE 2021-02-03

Smart SPACE Shoulder System

Applicant Techmah Medical, LLC

K-Number K202151

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BWK 2021-02-03

AXUS ES-5 Electro-Acupuncture Device

Applicant Lhasa Oms, Inc.

K-Number K200636

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KWD 2021-02-02

BioPoly Great Toe Hemiarthroplasty Implant

Applicant BioPoly, LLC

K-Number K203634

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FXX 2021-02-02

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

Applicant Ecoguard, Inc.

K-Number K202096

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LNH 2021-02-02

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K203553

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FXX 2021-02-02

Medical Face Mask

Applicant Gemtier Medical (Shanghai), Inc.

K-Number K202331

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JAK 2021-02-02

CTxx85 CT Scanner

Applicant Analogic Corporation

K-Number K201231

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MAX 2021-02-02

INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers

Applicant Globus Medical, Inc.

K-Number K203278

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FXX 2021-02-02

Disposable Medical Surgical Masks

Applicant Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.

K-Number K202323

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