3 results
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6ms
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Sources: EU EUDAMED, US FDA
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·February 13, 2013
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·August 15, 2012
ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015