73 results
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6ms
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Sources: EU EUDAMED, US FDA
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Enforcement
Class II
·Terminated·Water Pik, Inc.·August 15, 2018
Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 3, 2014
NGK Stem Ext 24 x 245mm
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·January 8, 2014
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 7, 2018
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 7, 2018
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 7, 2018