10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FRAGMENT PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
FIRST FILL R.C.S.
FDA 510(k)
FDA Class 2
·Dental
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
DIMENSION CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·June 13, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
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