50 results
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40ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Poseidon OCT Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
FDA 510(k)
FDA Class 2
·Radiology
INFRARED EAR THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024
UNKNOWN SAPPHIRE PUMP
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Injury
·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026
UNKNOWN SAPPHIRE PUMP
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 14, 2011
EXPRESS? VASCULAR SD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·June 11, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014
SAPPHIRE M.T INFUSION PUMP - GERMAN
FDA Adverse Event
Death
·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·April 20, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION, INC.·Product code KRD·April 17, 2026
SAPPHIRE M.T INFUSION PUMP - FRENCH
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION, INC.·Product code KRD·April 3, 2026
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 6, 2021
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·April 24, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION INC.·Product code KRD·January 14, 2025
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code HCG·May 28, 2026