136 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart G5 AED
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart® G3, G3 Plus and G5 AEDs
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart G5 AED
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart® G5 AED
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart® G5 AED
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart G5 Automated External Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart G5 Pediatric Electrodes
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart G5 AED
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart® G5
POWERHEART G5 AUTOMATIC AED
FDA Adverse Event
Malfunction
·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035750·6.5/7.3 Cannulated Tray
LEONE SPA
FDA UDI
LEONE SPA·08033707017097·CALIBRA 1ST MOLAR BANDS n.LR 33
BPR Medical
FDA UDI
BPR MEDICAL LIMITED·05060274501264·Microdial Flowmeter - Range A 0.02 - 3 l/min - ...
Rosie SmartMeter Glucose Control Solutions
FDA UDI
HMD BIOMEDICAL INC.·00868665000069·Rosie SmartMeter glucose control solution
JMS HARMONY A.V.FISTULA NEEDLE SET
FDA UDI
JMS SINGAPORE PTE LTD·08888483005505·HARMONY A.V.FISTULA 16GX1" BE 30CM W/CLAMP
JMS SYSLOC MINI AVF NEEDLE SET
FDA UDI
JMS SINGAPORE PTE LTD·08888483005574·SYSLOC MINI AVF 16GX1" BE 30CM W/CLAMP
TENDRIL MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·May 15, 2017
TENDRIL MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·May 15, 2017
ASSURITY MRI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code DXY·April 20, 2017