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