19 results
·
56ms
·
Sources: EU EUDAMED, US FDA
AORTIC PUNCH
FDA Adverse Event
Malfunction
·INTERNATIONAL BIOPHYSICS CORP.·Product code LRY·July 11, 2015
IBC FLOPUMP
FDA Adverse Event
Malfunction
·INTERNATIONAL BIOPHYSICS CORP.·Product code KFM·August 13, 2015
IBC FLOPUMP
FDA Adverse Event
Malfunction
·INTERNATIONAL BIOPHYSICS CORP.·Product code KFM·August 13, 2015
IBC SUCTION WAND
FDA Adverse Event
Malfunction
·INTERNATIONAL BIOPHYSICS CORP·Product code DTS·October 19, 2011
FLOPUMP 6000
FDA Adverse Event
Malfunction
·INTERNATIONAL BIOPHYSICS CORP·Product code KFM·November 22, 2013
IBC FLOW PUMP
FDA Adverse Event
Injury
·INTERNATIONAL BIOPHYSICS CORP.·Product code KFM·August 3, 2001
IBC FLOW PUMP
FDA Adverse Event
Malfunction
·INTERNATIONAL BIOPHYSICS CORP.·Product code KFM·August 11, 2001
IBC PROBE
FDA Adverse Event
Malfunction
·INTERNATIONAL BIOPHYSICS CORP.·Product code DTY·March 4, 1999
IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.
FDA Recall
Terminated
·International Biophysics Corp·Product code DTS·October 5, 2011
V MUELLER VASCULAR LOOPS MAXI BLUE STRL
FDA Adverse Event
Injury
·IBC (INTERNATIONAL BIOPHYSICS CORP)·Product code DWS·June 9, 2016
V MUELLER VASCULAR LOOPS MINI RED STRL
FDA Adverse Event
Injury
·IBC (INTERNATIONAL BIOPHYSICS CORP)·Product code DWS·June 9, 2016
IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.
FDA Recall
Terminated
·International Biophysics Corp·Product code DWE·August 16, 2005
IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX.
FDA Recall
Terminated
·International Biophysics Corp·Product code DPT·April 22, 2005
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.
FDA Recall
Terminated
·International Biophysics Corp.·Product code DWS·August 7, 2015
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
FDA Recall
Terminated
·International Biophysics Corp.·Product code DTS·August 7, 2015
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
FDA Recall
Terminated
·International Biophysics Corp.·Product code DWS·August 7, 2015
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.
FDA Enforcement
Class II
·Terminated·International Biophysics Corp.·August 26, 2015
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
FDA Enforcement
Class II
·Terminated·International Biophysics Corp.·August 26, 2015
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
FDA Enforcement
Class II
·Terminated·International Biophysics Corp.·August 26, 2015