12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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geko T-2 Neuromuscular Stimulator
FDA 510(k)
FDA Class 2
·Physical Medicine
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100547·LIEBERMAN SPECULUM SOLID SMALL
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019
BODYTOM NL 4000
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
FDA 510(k)
FDA Class 2
·Orthopedic
BD NANO¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 9, 2018
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FNL·October 8, 2014
MAXIMO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
SHAFT FOR 90 SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·September 21, 2022
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; 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