4 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
FDA Enforcement
Class II
·Ongoing·Human Care Hc Sweden Ab·April 17, 2024
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
FDA Enforcement
Class II
·Ongoing·HeartSine Technologies Ltd·August 6, 2025