15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIRAGE ACTIVA MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013
RUSCH CANTOR TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TALON BALLOON DILATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code GXZ·May 6, 2016
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 2, 2013
ARTERIAL LINE KIT
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES INC.·Product code GDY·March 22, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 17, 2008
DIGITAL PREAMPLIFIER
FDA Adverse Event
Malfunction
·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026
CONTROLLER ECLC ECLIPSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014
LIFEWISE BLOOD PRESSURE MONITOR
FDA Adverse Event
Injury
·RADIOSHACK·Product code DXN·October 20, 2004
IPC® HANDPIECE - STYLUS TOUCH®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·December 11, 2019
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