9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PACIFIER THERMOMETER MODELS VT-901F, VT901C
FDA 510(k)
FDA Class 2
·General Hospital
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·September 13, 2024
PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 12, 2024
3DKNEE
FDA Adverse Event
ENCORE MEDICAL, L.P.·Product code JWH·April 11, 2013
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·April 8, 2011
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYST
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR REDWOOD CITY·Product code FGE·May 22, 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