9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CARAPACE LABOR AND DELIVERY SETS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WEDGE, 20 DEG, UNCOV, 10X8.5X3
FDA UDI
ALIMED, INC.·00733657239751·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515241619·Killian Septum Spec, 64mm blds
I.T.S. EXTREMITY FIXATION SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
JSA REPROCESSED COMPRESSION SLEEVE DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 23, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·November 22, 2010
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Death
·HEARTWARE, INC·Product code DSQ·January 28, 2013
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014