BEUDAMED
    278 results · 19ms · Sources: EU EUDAMED, US FDA

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    T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·May 2, 2018

    T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·May 2, 2018

    Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and orthopedic trauma procedures. The intended part of the body will be the areas associated with the above procedures. These products will be used in a fully equipped OR suite by surgeons.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·May 1, 2019

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·June 19, 2019

    C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·October 9, 2019

    C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·October 9, 2019

    Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·February 12, 2020

    Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·February 12, 2020

    Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·May 6, 2020

    SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·February 12, 2020

    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

    FDA Enforcement
    Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·April 1, 2020

    SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·October 21, 2020

    SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 27, 2022

    Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 27, 2022

    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

    FDA Enforcement
    Class III ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 27, 2022

    VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.

    FDA Enforcement
    Class II ·Terminated·Skytron, Div. The KMW Group, Inc·October 14, 2020

    Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL

    FDA Enforcement
    Class II ·Ongoing·Shimadzu Corp. Analytical & Measuring Instruments Div.·December 4, 2024

    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

    FDA Enforcement
    Class II ·Ongoing·Shimadzu Corp. Analytical & Measuring Instruments Div.·December 4, 2024