11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORA IR22 EAR THERMOMETER, MODEL TD-1262
FDA 510(k)
FDA Class 2
·General Hospital
AMARA
FDA UDI
Respironics, Inc.·00606959007154·AMARA CUSHION, RP-LARGE
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 15, 2024
MFCD 120
FDA 510(k)
FDA Class 2
·Radiology
MOTION TRACKING
FDA 510(k)
FDA Class 2
·Radiology
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·May 15, 2020
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 2, 2013
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 16, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012