16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
PS SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PerforMax
FDA UDI
Respironics, Inc.·00606959007710·Performax Mask, with Standard Elbow, Single Use...
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EMA
FDA Adverse Event
Injury
·THE MYERSON COMPANY LIMITED·Product code LRK·November 7, 2023
EMA
FDA Adverse Event
Injury
·THE MYERSON COMPANY LIMITED·Product code LRK·November 7, 2023
EMA
FDA Adverse Event
Injury
·THE MYERSON COMPANY LIMITED·Product code LRK·November 6, 2023
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 28, 2013
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MQR·June 17, 2008
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·April 18, 2011
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·August 5, 2022
EMA
FDA Adverse Event
Injury
·THE MYERSON COMPANY LIMITED·Product code LRK·November 7, 2023
EMA
FDA Adverse Event
Injury
·THE MYERSON COMPANY LIMITED·Product code LRK·November 7, 2023
EMA
FDA Adverse Event
Injury
·THE MYERSON COMPANY LIMITED·Product code LRK·November 7, 2023
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·February 19, 2026
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015