BEUDAMED
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    JAZZ PF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331122293·Titanium Bipolar Bayonet Forceps, (malis type) ...

    DBX DEMINERALIZED BONE MATRIX PUTTY

    FDA 510(k)
    FDA Class 2 ·Dental

    MAC-MOBILE AQUATIC CHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·July 19, 2011

    LCP 1/3-TUB-PL 3.5 6HO L76 TI

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·June 26, 2013

    STERRAD NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·September 26, 2008

    COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020

    DEPTH GAUGE FOR 3.5MM CORTEX SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·July 22, 2021

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 8, 2012

    O-ARM O2 IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·SANMINA -SCI SYSTEMS·Product code OWB·February 9, 2023

    ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·July 31, 2019

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020