12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
FDA 510(k)
FDA Class 2
·Cardiovascular
GORNEY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055117·GORNEY SCISSORS STRAIGHT DOUBLE BEVELED TUNGSTE...
MODIFICATION TO M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 3015516266·Product code MBB·February 6, 2024
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 23, 2024
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHA·August 11, 2011
ENDO STITCH*POLYSORB* 2/0 48 VIO DLU SU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code KOG·October 24, 2014
TOTAL ASR FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 1, 2013
ONYX
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 8, 2023
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 8, 2023
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014