4 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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