35 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
FDA 510(k)
FDA Class 2
·Cardiovascular
INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 14, 2019
INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 19, 2019
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741726·Spinal Fusion Curette 7-3/4" (20cm), reverse an...
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE PERSONAL LUBRICANT (SILICONE)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 5, 2025
BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 14, 2023
PD1400 DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·October 3, 2008
SITTER II
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·July 29, 2011
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON MANUFACTURING, LTD.·Product code HQC·June 21, 2013
STEM: M-VIZION 01.22.102 DISTAL STEM 13MM L 140MM STRAIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 1, 2021
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 2, 2025
REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·December 11, 2025
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024
M-VIZION PROXIMAL BODY Ø20MM L 70MM LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 22, 2024
REVOLUTION CENTRIFUGAL BLOOD PUMP COATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·November 11, 2024
REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022
MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 20, 2023
REVOLUTION PHISIO CENTRIFUGAL PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021