39 results · 24ms · Sources: EU EUDAMED, US FDA

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VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

FDA 510(k)
FDA Class 2 ·Microbiology

TOWEL DRAPE, MODELS 4409, 4410

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

SOLAR SPO2 MODULE WITH MASIMO SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 19, 2024

UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 3, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 16, 2014

EAGLE EYE GOLD IVUS CATHETER

FDA Adverse Event
Malfunction ·VOLCANO CORPORATION·Product code OBJ·April 15, 2011

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015

ARCHITECT HE4 REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code OIU·February 6, 2026

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 8, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 17, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 25, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·November 6, 2014

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 9, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 28, 2015