21 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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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