16 results
·
17ms
·
Sources: EU EUDAMED, US FDA
3M MAXI-DRIVER II ELECTRIC SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Smith and Nephew Legion Hinge Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL TL-360 POWER SCOOTER
FDA 510(k)
FDA Class 2
·Physical Medicine
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·February 8, 2013
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
FDA Adverse Event
Injury
·COVIDIEN·Product code MCW·July 22, 2014
UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·January 6, 2011
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 30, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 11, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 11, 2021
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·July 24, 2021
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024