9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS
FDA 510(k)
FDA Class 2
·Orthopedic
TRACHEOSTOMY CARE KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
BECKER EDMS II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·June 19, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2015
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·December 14, 2012
TITANIUM PECTUS ELONGATED STAB
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·May 6, 2019
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020