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

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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HKI 2021-02-02

Fundus Camera

Applicant Huvitz Co., Ltd.

K-Number K202097

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FXX 2021-02-02

Disposable Medical Surgical Mask

Applicant Improve Medical (Hunan) Co., Ltd.

K-Number K202511

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FMI 2021-02-02

Easydrip Pen Needle, Easydrip Plus Pen Needle

Applicant Sandstone Medical (Suzhou), Inc.

K-Number K193422

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IZL 2021-02-02

EzRay M (Model: VMX-P300)

Applicant VATECH Co., Ltd.

K-Number K203667

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GEI 2021-02-02

CellFX System

Applicant Pulse Biosciences, Inc.

K-Number K203299

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