8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Symmetry Cushing
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482035856·Symmetry® Forceps, Cushing Bayonet Dressing, Se...
NEWGEN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VT-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T-FLEX ASPHERIC
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·April 19, 2013
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 25, 2011
SPECTRAFLEX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 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