15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ALADDIN MONITORING OXYGEN/AIR MIXER
FDA 510(k)
FDA Class 2
·Anesthesiology
ELECTRODE, BOVIE DISPERSIVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRIME BIG WHEEL STRETCHER, 30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·January 11, 2013
OPTIMIZED TIMESH SELF DRILL SCREW, 4.0MM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JEY·December 16, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 17, 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
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 13, 2016
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