27 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.
FDA Enforcement
Class II
·Terminated·Stryker Craniomaxillofacial Division·October 14, 2015
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler tip has been inserted into the pedicle. Next to the navigational information, these depth indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
FDA Enforcement
Class II
·Ongoing·Stryker Leibinger GmbH & Co. KG·May 15, 2024
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·February 15, 2017
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·February 15, 2017
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·September 5, 2018