2 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
FDA Enforcement
Class II
·Terminated·New Wave Endo-Surgical, Corp.·May 17, 2023
Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
FDA Enforcement
Class II
·Terminated·Aspen Surgical Puerto Rico Corp.·September 14, 2016