538 results · 31ms · Sources: EU EUDAMED, US FDA

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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