8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOFTIP CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STARKET MODEL HMS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2014
CE INFUSOR LV10, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 27, 2010
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·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