9 results · 18ms · Sources: EU EUDAMED, US FDA

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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