14 results
·
47ms
·
Sources: EU EUDAMED, US FDA
RAD-57
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·February 3, 2016
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
FDA Recall
Open, Classified
·The Biomed Guys·Product code FRN·March 25, 2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
FDA Enforcement
Class I
·Ongoing·The Biomed Guys·June 9, 2021
RAD-57
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·February 3, 2016
HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 28, 2012
SENSORMEDICS
FDA Adverse Event
Malfunction
·VIASYS RESPIRATORY CARE INC·Product code LSZ·August 28, 2007
IVENIX INFUSION SYSTEM
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA LLC·Product code FRN·December 3, 2024
SURGIWAND II
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GEI·November 4, 2010
BIRD
FDA Adverse Event
Malfunction
·VIASYS RESPIRATORY CARE INC·Product code CBK·February 27, 2007
IVENIX LARGE VOLUME INFUSION PUMP
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA, LLC·Product code FRN·March 28, 2024
B. BRAUN
FDA Adverse Event
Injury
·B BRAUN MEDICAL INC·Product code KDI·March 9, 2009
ERBE VIO 3
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·June 19, 2024
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·September 5, 2023
CMC Medical Devices & Drugs SL
Authorized representative
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