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

MAX 2020-08-26

MONDRIAN Lumbar Interbody Fusion Cage System

Applicant Ctl Medical Corporation

K-Number K192863

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MAX 2020-08-26

Adaptix Interbody System with Titan nanoLOCK Surface Technology

Applicant Medtronic Sofamor Danek

K-Number K201267

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FOZ 2020-08-26

Deltaven Fast Flash Closed I.V. Catheter Systems

Applicant Delta Med Spa

K-Number K200373

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FXX 2020-08-26

Single-use Surgical Mask

Applicant Byd Precision Manufacturer Co., Ltd.

K-Number K200923

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EMA 2020-08-26

Provicol QM Aesthetic

Applicant Voco GmbH

K-Number K201856

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DQX 2020-08-26

Hydrophilic Coating Guide Wire

Applicant Suzhou Hengrui Disheng Medical Co., Ltd.

K-Number K193653

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FXX 2020-08-26

Motex Anti-Fog Surgical Face Mask

Applicant Modern Healthcare Corp.

K-Number K201549

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LNH 2020-08-26

FIRMM

Applicant Nous Imaging, Inc.

K-Number K201141

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KWQ 2020-08-25

Cervical Plate System

Applicant Eminent Spine, LLC

K-Number K201979

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FMI 2020-08-25

Injection Pen Needle

Applicant Gangan Medical Technology Jiangsu Co., Ltd.

K-Number K192464

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LZA 2020-08-25

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K201772

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FLL 2020-08-25

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K193338

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