8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOTIS ANAEROBIC KBE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
JAKOBI SURG. INSTRUMENTS #11 11/13/14
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WALRUS EXTENSION SET COMPONENT
FDA Adverse Event
Malfunction
·ARROW INTL INC.·Product code FPA·June 11, 2010
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 20, 2014
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 21, 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 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