26 results
·
36ms
·
Sources: EU EUDAMED, US FDA
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000
FDA 510(k)
FDA Class 2
·Cardiovascular
BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001
FDA 510(k)
FDA Class 2
·Cardiovascular
BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER
FDA Adverse Event
Death
·BRIDGEPOINT MEDICAL INC.·Product code DQY·October 27, 2011
BRIDGEPOINT MEDICAL, CTO SYSTEM
FDA Adverse Event
Other
·BRIDGEPOINT MEDICAL INC.·Product code DQY·March 25, 2013
BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER
FDA Adverse Event
Injury
·BRIDGEPOINT MEDICAL INC.·Product code DQY·March 21, 2012
BRIDGEPOINT MEDICAL, INC CROSSBOSS CATHETER
FDA Adverse Event
Death
·BRIDGEPOINT MEDICAL INC.·Product code DQY·September 12, 2012
BRIDGEPOINT MEDICAL, INC. STINGRAY SYSTEM
FDA Adverse Event
Other
·BRIDGEPOINT MEDICAL, INC.·Product code DQY·June 21, 2012
BRIDGEPOINT MEDICAL INC STINGRAY SYSTEM
FDA Adverse Event
Other
·BRIDGEPOINT MEDICAL INC.·Product code DQX·May 18, 2012
BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER
FDA Adverse Event
Other
·BRIDGEPOINT MEDICAL INC.·Product code DQY·May 29, 2012
BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER
FDA Adverse Event
Other
·BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFIC·Product code DQY·May 29, 2013
BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER
FDA Adverse Event
Death
·BRIDGEPOINT MEDICAL, INC.·Product code DQY·December 3, 2012
BRIDGEPOINT MEDICAL, INC CROSSBOSS CATHETER
FDA Adverse Event
Death
·BRIDGEPOINT MEDICAL INC.·Product code DQY·September 12, 2012
BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER
FDA Adverse Event
Other
·BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFIC·Product code DQY·August 8, 2013
BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER
FDA Adverse Event
Other
·BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFC·Product code DQY·July 12, 2013
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
FDA Enforcement
Class II
·Terminated·Bridgepoint Medical·August 1, 2012
STINGRAY
FDA Adverse Event
Malfunction
·BRIDGEPOINT MEDICAL·Product code DQY·February 27, 2012
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
FDA Recall
Terminated
·Bridgepoint Medical·Product code DQY·June 26, 2012