8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MODIFIED TOUCH-ME-NOT MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
PMT ACCUPRESSURE INFUSION SYSTEM 3601
FDA 510(k)
FDA Class 2
·General Hospital
HOLDSTER ARM RETENTION SYSTEM
FDA 510(k)INRATIO PT/INR TEST STRIP
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·May 19, 2014
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 21, 2012
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM
FDA Adverse Event
Other
·HOLLISTER, INC.·Product code MIP·October 14, 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