8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
FDA 510(k)
FDA Class 2
·Ophthalmic
EIGEN FLORO-STOR FS-100
FDA 510(k)
FDA Class 2
·Radiology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 19, 2014
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·October 27, 2010
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 22, 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