BEUDAMED
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    Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade

    FDA 510(k)
    FDA Class 2 ·Neurology

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837087319·

    DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEVO COMFORT II

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·June 8, 2011

    SETROX S 60

    FDA Adverse Event
    Injury ·BIOTRONIK,GMBH AND CO.·Product code DTB·September 4, 2008

    C-QUR MOSAIC

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    ES2 CANNULATED MODULAR AWL

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·January 23, 2017

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 26, 2012

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026