32 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO KSEA ENDOTIP SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DASH 3000/4000 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ROSA ONE
FDA Adverse Event
Injury
·MEDTECH SA·Product code HAW·November 10, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·April 11, 2018
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·March 15, 2018
ROSA ONE
FDA Adverse Event
Injury
·MEDTECH SA·Product code HAW·June 15, 2018
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 10, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·March 21, 2018
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 16, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 9, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·January 26, 2018
CONSERVE(R) TOTAL NECK SLEEVE
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·April 10, 2013
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 2, 2014
TRINICA CERVICAL PLATE 1 LEVEL 26MM
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code KWQ·April 7, 2011
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 6, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·August 3, 2018
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·January 10, 2018
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 16, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·June 6, 2018