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

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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