15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDGRAPHICS ULTIMA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
AF531
FDA UDI
Respironics, Inc.·00606959007284·AF531 Mask with Standard Elbow with CapStrap, S...
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AVID-NIT LOSS OF RESISTANCE SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013
ST JOSEPHS PHOENIX, AZ 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code DWF·July 31, 2009
RU NOVOSIBRIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·October 16, 2013
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
ENCORE ACETABULAR SYSTEMS
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWB·June 16, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
CP87641 GB SOUTHAMPTON
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·March 22, 2010
D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015