15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
LIFETECH CASSETTE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PASS OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDLOG, MODEL 1-0-10
FDA 510(k)
FDA Class 2
·Cardiovascular
REPAIR SYS6 ST ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·December 16, 2010
MOTOR EM210 LEGEND STYLUS TOUCH
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC·Product code ERL·February 14, 2013
ATTUNE PS RP INSRT SZ6 5MM
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code NJL·July 28, 2014
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·August 12, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
CG COMPOSITE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 29, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 19, 2022
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024