21 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AEQUALIS REVERSED PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

AXON ECLIPSE CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013

MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ORTHOCEPH OC100 D

FDA 510(k)
FDA Class 2 ·Dental

NIM-ECLIPSE® CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code GWF·February 20, 2018

AXON ECLIPSE CONTROLLER

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 2, 2013

NIM-ECLIPSE® PATIENT MODULE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 6, 2017

PROBE SPK1004 SURGEON CONTROLLED

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·May 17, 2013

NIM-ECLIPSE® CONTROLLER

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 14, 2015

NIM-ECLIPSE® CONTROLLER

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

COMPUTER NOTEBOOK (INTERNATIONAL

FDA Adverse Event
Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013

TAPERGUARD EVAC

FDA Adverse Event
Malfunction ·COVIDIEN NELLCOR MALLINCKRODT·Product code BTR·March 30, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 17, 2008

DELTEC GRIPPER PLUS NEEDLES

FDA Adverse Event
Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·May 21, 2025

CONTROLLER ECLC ECLIPSE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014

NIM-ECLIPSE PREAMPLIFIER

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 7, 2021

COMPUTER NOTEBOOK (INTERNATIONAL)

FDA Adverse Event
Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·April 13, 2026

RD SET NEO CS-3

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012