10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICRO-EMED-SYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
AXSOS
FDA UDI
Stryker GmbH·07613154482610·Lid for Base - Femur Implants TS
M2376A DEVICELINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016
PORTEX® BIVONA® AIRE-CUF® ADULT TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014
NONIN AVANT MODEL 9600
FDA Adverse Event
Death
·NONIN MEDICAL, INC.·Product code DQA·January 4, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2010
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