30 results · 22ms · Sources: EU EUDAMED, US FDA

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SAVI APPLICATOR KIT

FDA 510(k)
FDA Class 2 ·Radiology

BABY DOPPLEX 4000 (BD4000)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016

IPC® STYLUS TRANSNASAL BUR

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·February 6, 2015

IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

FDA Adverse Event
Malfunction ·MEDTRONIC, INC·Product code ERL·June 19, 2015

INRATIO PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 18, 2016

XPS® BUR

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·September 8, 2017

ACCY EF201 IPC FOOT CONTROL ROHS

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code HBE·September 9, 2014

XPS® BUR - UNKNOWN

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code EQJ·June 17, 2016

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 9, 2011

BOSTON SCIENTIFIC

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code DQX·July 10, 2008

INRATIO PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 29, 2016

XOM UNKNOWN ENDO

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code EQJ·May 8, 2015

XPS® HANDPIECE - UNKNOWN

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code HBE·November 8, 2016

IPC® FOOTPEDAL

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·March 1, 2016

XPS® HANDPIECE - UNKNOWN

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code HBE·October 17, 2017

INVICTUS SPINAL FIXATION SYSTEM

FDA Adverse Event
Injury ·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025