8 results
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30ms
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Sources: EU EUDAMED, US FDA
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG
FDA 510(k)
FDA Class 2
·Orthopedic
COLLAGEN PERIODONTAL MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
FDA 510(k)
FDA Class 3
·Cardiovascular
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 9, 2013
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 7, 2011
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 9, 2024
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