9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
AUTO-TENS MODEL I DISPOS. SINGLE CHAN
FDA 510(k)
FDA Class 2
·Neurology
Partial Pelvis Replacement
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575200894·4 hole flanges,with caudal flange
HCP DICOM NET
FDA 510(k)
FDA Class 2
·Radiology
VS3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LCS COMP RP INSERT LG+ 10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·May 21, 2014
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 5, 2012
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 25, 2010
4.5MM CORTEX SCREW 42MM
FDA Adverse Event
Malfunction
·SYNTHES GRENCHEN·Product code HWC·September 21, 2016
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012