11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bladeless Optical Obturators
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AED RESECTOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INO THERAPEUTICS INOBLENDER, MODEL 10004
FDA 510(k)
FDA Class 2
·Anesthesiology
MIS SINGLE INNER SETSCW
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·August 27, 2019
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·June 7, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 7, 2011
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·September 10, 2008
VERSAFITCUP CC TRIO NO HOLE CEMENTLESS CUP Ø 58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 10, 2015
BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 18, 2018
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
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