32 results · 24ms · Sources: EU EUDAMED, US FDA

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Sera

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

FDA 510(k)
FDA Class 2 ·Orthopedic

LIFEPAK 15 MONITOR/DEFIBRILLATOR

FDA 510(k)
FDA Class 3 ·Cardiovascular

AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 30, 2018

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·April 3, 2020

PULSE GEN MODEL 102R

FDA Adverse Event
Injury ·CYBERONICS INC·Product code LYJ·October 15, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 17, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·August 26, 2019

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·September 26, 2018

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·February 4, 2020

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·July 9, 2019

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·July 3, 2019

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·October 12, 2019

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·August 7, 2019

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·February 11, 2020

BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·December 12, 2018

AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·May 3, 2019

MOB)

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DQY·April 8, 2019