9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·January 14, 2019
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BRAIN COIL, MODEL 9800GE-64
FDA 510(k)
FDA Class 2
·Radiology
QUIK-COMBO PACING/DEFIBRILLATION/ECG
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
MARQUIS DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·April 13, 2011
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·May 23, 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