12 results · 21ms · Sources: EU EUDAMED, 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