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

OBP 2018-05-04

Apollo TMS Therapy System

Applicant Mag & More GmbH

K-Number K180313

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DZE 2018-05-04

URIS OMNI System

Applicant Truabutment, Inc.

K-Number K172100

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MBH 2018-05-04

EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System

Applicant Microport Orthopedics, Inc.

K-Number K180317

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MVL 2018-05-03

Smartcord, Smartcord X

Applicant Eastdent Co., Ltd.

K-Number K171577

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PSN 2018-05-03

VivaScope System

Applicant Caliber Imaging & Diagnostics, Inc.

K-Number K180162

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OBP 2018-05-03

Brainsway Deep (DTMS) System

Applicant Brainsway , Ltd.

K-Number K173540

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DQX 2018-05-03

Medtronic Confida Brecker Guidewire

Applicant Medtronic Core Valve, LLC

K-Number K181001

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DZI 2018-05-03

PIEZOTOME CUBE

Applicant Satelec - Acteon Group

K-Number K172137

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QEW 2018-05-03

Indigo Aspiration System - Modified 110 Aspiration Tubing

Applicant Penumbra, Inc.

K-Number K180939

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IZI 2018-05-03

CAAS Workstation

Applicant Pie Medical Imaging BV

K-Number K180019

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FBK 2018-05-03

Repris Bladder Injection System

Applicant Uro-1, Inc.

K-Number K180214

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NBL 2018-05-03

Fluorescence Mode

Applicant Carl Zeiss Suzhou Co., Ltd.

K-Number K171007

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