9 results
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18ms
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Sources: EU EUDAMED, US FDA
BONALIVE GRANULES AND BONALIVE PLATES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRULINE INFUSION CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
MEDLINE ELECTRONIC POSITIONING CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·April 22, 2013
GORE DRYSEAL SHEATH
FDA Adverse Event
Death
·W. L. GORE & ASSOCIATES·Product code DYB·April 25, 2011
INTRINSIC
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·July 10, 2008
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012
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