23 results · 23ms · 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.

BIO-PREP CEMENT RESTRICTOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

JEJUNOSTOMY KIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CARDIOVATIONS RETRACTOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GRANUFLO

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 24, 2014

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 28, 2013

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·December 10, 2010

BCD VANGUARD

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·March 4, 2022

SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·November 20, 2020

CARDIOPLEGIA HEAT EXCHANGER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·April 29, 2020

SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 12, 2019

BCD VANGUARD N/S

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·January 15, 2024

CELLEX PHOTOPHERESIS SYSTEM

FDA Adverse Event
Malfunction ·MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED·Product code LNR·November 28, 2022

SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·January 28, 2019

SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·March 22, 2019

NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·November 25, 2022

SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 5, 2021

SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·March 5, 2021

SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·March 5, 2021

SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·January 12, 2022

CARDIOPLEGIA HEAT EXCHANGER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTN·December 23, 2019