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

ELW 2022-02-11

IMICRYL Impression Materials

Applicant Imicryl Dis Malzemeleri San. VE Tic. A.S.

K-Number K213890

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KWQ 2022-02-11

3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System

Applicant Orthofix US, LLC

K-Number K211712

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MSX 2022-02-11

Zyter RPM

Applicant Zyter, Inc.

K-Number K212622

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HGX 2022-02-11

Electric Breast Pump

Applicant Shantou Huihengqi Electronic Technology Co., Ltd.

K-Number K211024

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HSB 2022-02-11

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

Applicant Stryker GmbH

K-Number K213328

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FOZ 2022-02-11

B. Braun Introcan Safety 2 IV Catheter

Applicant B.Braun Medical, Inc.

K-Number K213664

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IZL 2022-02-11

EzRay M18 (Model: VMX-P400)

Applicant VATECH Co., Ltd.

K-Number K213462

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FDF 2022-02-10

Pure-Vu EVS System

Applicant Motus GI Medical Technologies , Ltd.

K-Number K220007

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IPL 2022-02-10

Action Trackchair Hawk

Applicant Action Manufacturing, Inc.

K-Number K202728

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OKO 2022-02-10

NPseal

Applicant Guard Medical, Inc.

K-Number K212971

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JXI 2022-02-10

NervAlign Nerve Cuff

Applicant Renerve, Ltd.

K-Number K202234

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HSB 2022-02-10

GPC Intraheal Intramedullary Nailing System

Applicant Gpc Medical Limited

K-Number K203811

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