12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SENORX BIOPSY DEVICE II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496040842·FITNESS, SIZE XL, MOKA, GRADUATED COMPRESSION 1...
LYNX
FDA UDI
HNM TOTAL RECON LLC·00841742110769·LYNX ø3.5mm Std Cortical Screw, Full Thread, Se...
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ERTAPENEM 10UG BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 8, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 21, 2011
GE OE 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·May 9, 2008
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024