8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
FDA 510(k)
FDA Class 3
·Cardiovascular
MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
FDA 510(k)
FDA Class 2
·Anesthesiology
PARAMAX COMPREHENSIVE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOVENT PULMONARY VENT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·June 16, 2014
BIOMET INTERLOK 83MM FIXED CRUCIATE TIBIAL PLATE W/ LOCKING BAR
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code JWH·October 19, 2010
LAMTITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 13, 2012
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012