21 results · 24ms · Sources: EU EUDAMED, US FDA

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TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

AXON ECLIPSE CONTROLLER

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

ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

INTERMED ZOOM COLPOSCOPE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

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

EDWARDS SAPIEN TRANSCATHETER HEART VALVE

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code NPT·April 8, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·March 10, 2011

VITALITY DR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

FDA Enforcement
Class II ·Terminated·Stryker GmbH·July 18, 2018

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

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

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