10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ACHELASIA BALLOON DIALATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST Travel Sock
FDA UDI
BSN MEDICAL, INC.·00035664013042·TRAVEL SOCKS 15-20 MM HG KNEE HIGH CLOSED TOE S...
Archon
FDA UDI
Nuvasive, Inc.·00887517325662·Archon Driver, Vertical Clip
TRANSPORT CULTURE MEDIA
FDA 510(k)
FDA Class 1
·Microbiology
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
FDA 510(k)
FDA Class 2
·Ophthalmic
ELLIPSE DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 19, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·October 25, 2010
PASSING PINS & GUIDE
FDA Adverse Event
Malfunction
·MANSFIELD MANUFACTURING SITE·Product code HWE·December 25, 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