7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11
FDA 510(k)
FDA Class 2
·Radiology
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LM 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIOSAVE
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·April 25, 2014
SELECT SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 19, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015