20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEX-MT +
FDA 510(k)
FDA Class 2
·Physical Medicine
Oticon
FDA UDI
Oticon A/S·05707131270092·H16, DESIGNRITE 10 WL STG
VITALAB URIC ACID REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2018
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 3, 2014
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 2011
GMK REVISION SC LINER SIZE 2 / 10 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 27, 2015
BD VIPER¿ LT SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023
BD PHOENIX PMIC110
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·October 19, 2021
BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·August 23, 2021
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
BD PHOENIX PANEL PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
PANEL PHOENIX PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 9, 2025
BD PHOENIX PANEL PMIC-110
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 10, 2023
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019