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

FPA 2020-08-26

TK Intravascular Administration Set

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K-Number K191640

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LLZ 2020-08-26

AVIEW

Applicant Coreline Soft Co., Ltd.

K-Number K200714

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GCJ 2020-08-26

VersaOne Reusable Positioning Trocar System

Applicant Covidien

K-Number K201805

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QAS 2020-08-26

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K201020

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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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