8 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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BIS EEG MONITOR VIEW
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REPROCSSED LINVATEC SHAVERS
FDA 510(k)
FDA Class 2
·Orthopedic
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 18, 2013
ENDOPLEGE SINUS CATHETER
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DWF·June 18, 2008
ADVANTAGE SERIES 29
FDA Adverse Event
Injury
·STRYKER MEDICAL·Product code FPO·April 8, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015