71 results
·
34ms
·
Sources: EU EUDAMED, US FDA
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Injury
·RAND S.R.L.·Product code DTQ·May 26, 2010
PERFORMER HT
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code LGZ·October 1, 2014
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Injury
·RAND S.R.L.·Product code DTQ·July 24, 2000
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code DWB·May 31, 2007
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Injury
·RAND S.R.L.·Product code DTQ·March 2, 2007
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Injury
·RAND S.R.L.·Product code DTQ·February 24, 2011
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code DTQ·November 22, 2006
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code DTQ·November 22, 2006
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code DTQ·November 22, 2006
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code DTQ·November 30, 2006
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Injury
·RAND S.R.L.·Product code DTQ·August 28, 2009
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Injury
·RAND S.R.L.·Product code DTQ·August 18, 2007
PERFORMER CPB SUPPORT SYSTEM
FDA Adverse Event
Injury
·RAND S.R.L.·Product code DTQ·February 6, 2009
HANG&GO HT BASIC
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code LGZ·May 15, 2017
Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DTQ·June 4, 2007
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
FDA Enforcement
Class II
·Terminated·RanD S.r.l.·July 21, 2021
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
FDA Enforcement
Class II
·Terminated·RanD S.r.l.·July 21, 2021
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
FDA Recall
Terminated
·RanD S.r.l. Strada Statale 62 Medolla Italy·Product code LGZ·April 30, 2021
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
FDA Recall
Terminated
·RanD S.r.l. Strada Statale 62 Medolla Italy·Product code LGZ·April 30, 2021
Albo Land S.r.l.
Manufacturer
🇮🇹 Italy·3 Basic UDI-DIs·4 Devices