11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Helios III
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUCINA-MELODI
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIROCCO THERMAL REGULATING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 19, 2023
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·June 8, 2013
CONMED GOLDLINE 'A' ROCKER SWITCH PENCIL
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·June 28, 2011
LCS REV FEM 75MM LG RT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·September 5, 2008
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023