31 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MAGIC Infusion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113387·ALIO MICS TRAP KNIFE (BX/5)
QUEST MPS BACK-UP SYSYEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CELSIUS CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024
TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code OAE·March 28, 2023
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code LPH·October 27, 2014
MODEL NOT SPECIFIED
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 2, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
VALIANT CAPTIVIA UNK
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·September 23, 2025
ENDURANT II STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 27, 2025
VALIANT CAPTIVIA UNK
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·May 7, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·May 7, 2024
ACHIEVE MAPPING CATHETER - 20 MM
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·April 25, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·May 7, 2024
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·April 25, 2024
ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code OAE·March 16, 2023