7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XELERIS 2 PROCESSING AND REVIEW WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 10, 2013
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011
PROXIMAL CATHETER
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·May 21, 2008
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