21 results
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78ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·August 15, 2012
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
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·November 7, 2012
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
"***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012
"***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
"***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
"***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
"***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·October 24, 2012
GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·July 10, 2013
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
"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·November 28, 2012
D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
FDA Enforcement
Class III
·Terminated·Linvatec Corp. dba ConMed Linvatec·March 13, 2013
D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
FDA Enforcement
Class III
·Terminated·Linvatec Corp. dba ConMed Linvatec·March 13, 2013
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·July 17, 2013
"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·November 28, 2012
***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·July 17, 2013