10 results
·
35ms
·
Sources: EU EUDAMED, US FDA
GEN-X 800/6/50
FDA 510(k)
FDA Class 2
·Radiology
In-Situ Repositioning Sheet Medium
FDA UDI
SILVALEA LIMITED·05056387438900·
In-Situ Repositioning Sheet Extra Large
FDA UDI
SILVALEA LIMITED·05056387438924·
In-Situ Repositioning Sheet Large
FDA UDI
SILVALEA LIMITED·05056387438917·
AMC
FDA UDI
Advantage Medical Electronics, LLC·00849593016865·GE ECG w/1 Abbott IBP Connections Outer
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
FDA 510(k)
FDA Class 1
·Microbiology
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·January 10, 2013
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014