8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS DRM ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Brigade
FDA UDI
Nuvasive, Inc.·00887517964472·Brigade Lateral Trial, 15x34x28mm 12°
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTALVISION
FDA 510(k)
FDA Class 2
·Radiology
FORTIFY ASSURA ST DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 26, 2007
BD VACUTAINER ECLIPSE NEEDLE
FDA Adverse Event
Injury
·BD·Product code FMI·January 4, 2013
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