7 results
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59ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·November 6, 2019
A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·November 6, 2019
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·November 6, 2019
A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·November 6, 2019
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·November 6, 2019
Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·March 7, 2018
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.
FDA Enforcement
Class II
·Terminated·Alto Development Corp·August 7, 2019