8 results
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24ms
·
Sources: EU EUDAMED, US FDA
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CONVOY ADVANCED DELIVERY SHEATH KIT
FDA 510(k)
FDA Class 1
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 21, 2026
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·LIVANOVA USA, INC.·Product code LYJ·April 17, 2013
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 12, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 19, 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