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

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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KPR 2021-02-01

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems

Applicant Sedecal., Sa.

K-Number K203537

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GAT 2021-02-01

FAST-FIX FLEX

Applicant Smith & Nephew, Inc.

K-Number K203393

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MBI 2021-02-01

HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture

Applicant Medos International SARL

K-Number K203794

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KGO 2021-02-01

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves

Applicant Guilin Hbm Health Protections, Inc.

K-Number K203483

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GCJ 2021-02-01

Monopolar Hook

Applicant Human Xtensions , Ltd.

K-Number K203603

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KTT 2021-02-01

Hoffmann LRF System

Applicant Stryker GmbH

K-Number K203568

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KWQ 2021-01-29

Prase-AP Anterior Cervical Plate System

Applicant Gbs Commonwealth Co., Ltd.

K-Number K202878

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