54 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AxSOS 3 AF System and AxSOS 3 Ti System
FDA 510(k)
FDA Class 2
·Orthopedic
HERMETIC LUMBAR CATHETER, CLOSED TIP
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·September 26, 2016
HERMETIC LUMBAR CATHETER, CLOSED TIP
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·April 24, 2017
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
FDA 510(k)
FDA Class 2
·Hematology
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2025
MPACT EXTENSION
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 2, 2026
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 18, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2024
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·December 9, 2019
AMISTEM-P
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 26, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 19, 2025
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 13, 2025
LINER: MPACT FLAT PE HC LINER Ø28/B
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 3, 2022
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 1, 2013
IMPLANTABLE NEUROSTIMULATOR FOR DBS
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·March 4, 2016