8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GASTRIN RIA MODULE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RTX3370
FDA 510(k)
FDA Class 2
·Cardiovascular
Bard Mission Disposable Core Biopsy Instrument
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 25, 2014
SCREW
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·September 28, 2012
PUMP MMT-712WWB PRDGM INSULIN BL EN PR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 22, 2010
Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1: Part #731419 KIT; FOC MXP 2.0 UPGRADE KIT; Part #731418 SWRE KIT; MXP 2.0 NEW USER; Part #772145 MXP 2.1 FOC Upgrade Kit; 771938 MXP 2.1 Software; Part #771952 FOC MXP 2.1 Upgrade Kit; Part #771953 New User MXP 2.1 Kit. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKZ·August 29, 2006
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