12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
AUTO-LYTE BARBITURATES EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
DEGUFILL (TM)
FDA 510(k)
FDA Class 2
·Dental
IMP CBL DIA2 SS CABLE SLEEVE
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 18, 2016
IMP CBL DIA2 SS CABLE SLEEVE
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 18, 2016
IMP CBL DIA2 SS &CABLE SLEEV
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 30, 2016
IMP CBL DIA2 SS & CABLE SLEEVE
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDQ·July 20, 2016
10.5 CM ANGLE ATTACHMENT, BLACK MAX
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HSZ·February 25, 2013
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 24, 2014
HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·January 6, 2011
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet 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 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet 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