19 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
***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
Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·May 29, 2013