12 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TLS TM SURGICAL DRAINAGE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209112975·
ACUMED
FDA UDI
Acumed LLC·10806378043178·Univ Tray Low Prof Clav Trial Lid
VB IMAGE VIEWER
FDA 510(k)
FDA Class 2
·Radiology
MAEDA NEW NEEDLE DISPOSABLE
FDA 510(k)
FDA Class 2
·General Hospital
CLARION IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·February 11, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS·Product code MUZ·October 22, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 12, 2010
BD PLATE CAMPYLOBACTER SB 100MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022
NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis.
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·June 22, 2009
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
FDA Recall
Terminated
·Product code LZG·February 13, 2020
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021