7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 4070 TEMPERATURE MONITOR
FDA 510(k)
FDA Class 2
·General Hospital
CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
FDA 510(k)
FDA Class 2
·Cardiovascular
BIAD NUCLEAR IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2014
CURRENT RF DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2010
LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·January 3, 2013
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 14, 2013