27 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
FDA 510(k)
FDA Class 2
·Immunology
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446946007·SPECIAL, EMPOWR KNEE TIBIAL STYLUS, 6/8
Blade Handle
FDA UDI
KATENA PRODUCTS, INC.·00841668112380·BARD-PARKER HANDLE #3
TRIDENT ALL POLY CUP
FDA 510(k)
FDA Class 2
·Orthopedic
MHS MED LIGHT 1000
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 22, 2015
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026
TRIFECTA VALVE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)·Product code LWR·August 5, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 17, 2014
STRETCHER CHAIR
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 2, 2013
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·December 31, 2015
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 14, 2019
MEDTRONIC ICD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·April 21, 2020
CG COMPOSITE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 16, 2020
ENDURANT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·May 30, 2019
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 30, 2019
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 30, 2019
CONTOUR 3D ANNULOPLASTY RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 16, 2020
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·January 29, 2020