10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MCG-S (AM1000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Innomed NPWT Silicone Foam Dressing
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDICHEART, MODEL RELEASE 1
FDA 510(k)
FDA Class 2
·Radiology
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
DURAL ALPHA INSERT NEUTR II/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 29, 2025
HEARTSTING III PROXIMAL SEAL SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIOVASCULAR·Product code DXC·October 31, 2008
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 2, 2011
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·July 18, 2013
ALLOFIT ALLOCLAS SHELL 52/II
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·September 29, 2025
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
FDA Recall
Terminated
·Synthes, Inc.·Product code FZX·February 17, 2015