31 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)
ZSFab Cervical Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113547·SLIT BLADE 3.2MM ANGLED (BX/5)
KELO-COTE TOPICAL GEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MODEL OBC-63 BREAST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·December 16, 2013
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·December 4, 2012
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·March 9, 2012
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·March 17, 2021
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·February 27, 2014
LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MKJ·May 27, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2008
ACCU-CHECK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·August 5, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·January 13, 2014
WOLVERINE CORONARY CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NWX·August 11, 2025
MEDTRONIC CRT-D
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NIK·August 21, 2024
MEDTRONIC CRT-D
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NIK·August 22, 2024
ATTAIN PERFORMA S MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OJX·November 18, 2024