BEUDAMED
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    DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70606401·Sprint II Bracket Roth .018" 1000 Brackets

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481475227·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0606000·Tray, Base, 6"

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862284808·LOGIC CC FEM BOX TRIAL SIZE 4 LEFT

    Truliant CC

    FDA UDI
    Exactech, Inc.·10885862625991·TRULIANT CC MODULAR FEMORAL BOX TRIAL SIZE 4 LEFT

    SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KSEA SCB MEDIA CONTROL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Widex

    FDA UDI
    Widex A/S·05706069679113·Widex EVOKE E-CIC-M TR (Light beige ) 440

    Widex

    FDA UDI
    Widex A/S·05706069679137·Widex EVOKE E-CIC-M TR (Dark brown ) 440

    Widex

    FDA UDI
    Widex A/S·05706069679120·Widex EVOKE E-CIC-M TR (Clay brown ) 440

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·March 28, 2013

    ASR ACETABULAR IMPLANT 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 6, 2011

    MENTOR OBTAPE

    FDA Adverse Event
    Injury ·MENTOR CORP.·Product code FTL·June 10, 2008

    EDWARDS LOCKING SYRINGE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·June 16, 2023

    EDWARDS LOCKING SYRINGE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES LLC·Product code MAV·March 29, 2022

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018