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Sources: EU EUDAMED, US FDA
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Status: Terminated
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D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Dry hemostatic bandage (D-Stat Dry) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Adhesive bandage
FDA Recall
Terminated
·Vascular Solutions, Inc.·Product code FRO·September 9, 2005
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
FDA Enforcement
Class III
·Terminated·DeVilbiss Healthcare LLC·July 9, 2014
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