BEUDAMED
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    SKYHAWK INTERBODY FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037301524·HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +9

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649644·INTREPED 09 Universal Depth Stop

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037303559·TRIAL HUMERAL CUP 135/145° STANDARD Ø40 +9

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037314135·STABILITY TRIAL HUMERAL CUP CUSTOM MADE 135/145...

    EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROTOS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 15, 2015

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 8, 2015

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·October 3, 2014

    TRIDENT 10° X3 INSERT 32MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·May 31, 2013

    POSEY STAYSAFE BED

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code FNL·June 15, 2011

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

    EXPRESSEW III W/HOOK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code LXH·July 16, 2019

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013