3 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
FDA Enforcement
Class II
·Ongoing·Wondfo USA Co Ltd·June 19, 2024
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
FDA Enforcement
Class II
·Terminated·Irvine Biomedical Inc, a St. Jude Medical Co.·September 30, 2020
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
FDA Enforcement
Class II
·Terminated·Irvine Biomedical Inc, a St. Jude Medical Co.·September 30, 2020