8 results
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26ms
·
Sources: EU EUDAMED, US FDA
BLOOD-SOLUTION ADMINISTRATION SET, SURG.
FDA 510(k)
FDA Class 1
·General Hospital
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Burn-out Cylinder and Angled Screw Abutments
FDA 510(k)
FDA Class 2
·Dental
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 21, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·September 26, 2012
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·July 2, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025