9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
0.014 Willow Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857369955·Trial, Size 12x14x12 mm, 25°
SimPro Now, GentleCath Hydrophilic
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 3, 2018
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 11, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 29, 2011
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025