27 results
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24ms
·
Sources: EU EUDAMED, US FDA
SYNELISA RO ABS / LA ABS
FDA 510(k)
FDA Class 2
·Immunology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515237544·Replaceable Nylon Caps for 93-0210, PAIR
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8039302090·LONG COBB CURETTE 15" CURVED #2
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
FDA 510(k)
FDA Class 2
·Cardiovascular
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
LRG TAP PRI MOD NCK 0DEG 34MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 25, 2013
COMBISET WITH BVM
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FJK·November 18, 2010
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 11, 2014
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 3, 2024
HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 10, 2019
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 10, 2017
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·August 3, 2022
INSPIRE 6 HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·February 25, 2022
INSPIRE 6
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL.·Product code DTZ·July 15, 2024
INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 17, 2018
INSPIRE 6F DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VEN/CARD RES
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 24, 2018
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 23, 2022
INSPIRE 6 STERILE
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL.·Product code DTZ·February 1, 2024