8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SYRINGE, ENT
FDA 510(k)
FDA Class 1
·General Hospital
SYNCHRON MULTI CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ClearPath Disposable Introducer
FDA 510(k)
FDA Class 2
·Neurology
DELTAFILL10 6MM X 16CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·October 5, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 14, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 24, 2007
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 31, 2012
ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016