8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DEFIGARD 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
OP-CON SURG. INSTRUMENTS #11
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENTERNAL FEEDING TUBE-POLYURETHANE EF504
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 6, 2014
PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JEY·December 3, 2012
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, IRVINE·Product code OAD·September 3, 2010
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012