210 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HYPERION MEDICAL
FDA registration
HYPERION MEDICAL·5 products·🇺🇸 United States
BLUE SHINE LASER
FDA Adverse Event
Injury
·HYPERION MEDICAL·Product code GEX·May 8, 2012
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·September 20, 2018
BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 32/+7, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·January 10, 2019
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·March 25, 2019
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·April 26, 2019
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
FDA Recall
Terminated
·Hyperion Medical·Product code PDZ·November 20, 2013
0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·December 19, 2018
ARROW CATH-LAB SHEATH INTRO SET
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·June 15, 2022
ARROW CATH-LAB SHEATH INTRO SET:
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·July 13, 2022
NC TRAVELER CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·December 20, 2016
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
FDA Enforcement
Class II
·Terminated·Hyperion Medical·August 27, 2014
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·August 19, 2014
NC TRAVELER CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·November 21, 2016
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 29, 2019
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 10, 2019
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·March 26, 2018
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 27, 2017
NC TRAVELER CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·May 11, 2015
TENKU DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·November 24, 2014