538 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040128012·LONG LIGATURE TIES KOBAYASHI .014
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
FDA 510(k)
FDA Class 2
·Microbiology
ELCAM STOPCOCKS AND MANIFOLDS
FDA 510(k)
FDA Class 2
·General Hospital
ACCESS TRAY
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code KGZ·April 12, 2013
NATURAL-KNEE HEX HEAD SCREWDRIVER BIT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HXX·March 18, 2011
ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 19, 2008
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
FDA Recall
Open, Classified
·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·September 26, 2025
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·November 19, 2025
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 20, 2011
OT ULTRA METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 3, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 27, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 3, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 6, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 1, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 16, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 19, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 22, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 30, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 2, 2011