258 results · 33ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ELM PTA BALLON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

LONG LENGTH DYAX NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)

FDA 510(k)
FDA Class 2 ·Cardiovascular

EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code MUM·December 10, 2019

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code MQR·April 7, 2022

EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code MQR·June 15, 2021

TROCHANTERIC NAIL KIT, TI GAMMA3 11X80MM X 125

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012

RESTORE ADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2013

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

TRIO MOBILE SURGY PLTFRM

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·May 25, 2011

EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code MUM·September 9, 2019

REMSTAR AUTO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 20, 2021

REMSTAR PRO

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·August 20, 2021

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code MQR·October 18, 2018

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code MQR·August 20, 2020

EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code MUM·September 1, 2020

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code MQR·August 20, 2020

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code MQR·May 31, 2019

EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code MQR·April 25, 2019

EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code MUM·February 15, 2023