210 results · 39ms · Sources: EU EUDAMED, 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