9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALLEVYN AG DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
PERFORMATRAK
FDA UDI
Respironics, Inc.·00606959004245·PerformaTrak Full Mask, Large, with CapStrap, S...
GLOBAL HEALTHCARE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JAS MAGNESIUM REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 18, 2025
POSEY SITTER ELITE
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·April 3, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 19, 2008
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·April 7, 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