BEUDAMED
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    BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964070495·Endo Carry-On Procedure Kit

    Oticon

    FDA UDI
    Oticon A/S·05707131160096·SAFARI 300, BTE DBL

    SYNC-RX SYSTEM, MODEL AS00010

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Widex

    FDA UDI
    Widex A/S·05706069722499·Widex D-PA BTE (Tan silk S-440 ) RC coil

    Widex

    FDA UDI
    Widex A/S·05706069722116·Widex D-FS BTE (Tan silk S-440 ) Telecoil, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069726992·Widex EVOKE E-PA (Tan silk S-440 ) RC coil

    Widex

    FDA UDI
    Widex A/S·05706069721263·Widex BEYOND B-F2 (Tan silk S-440 ) Telecoil, R...

    Widex

    FDA UDI
    Widex A/S·05706069721799·Widex UNIQUE U-FS BTE (Tan silk S-440 ) Telecoi...

    Widex

    FDA UDI
    Widex A/S·05706069720983·Widex UNIQUE U-PA BTE (Tan silk S-440 ) RC coil

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code FZP·August 11, 2020

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 9, 2013

    NEUROMONITOR BASIC KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code GWM·September 19, 2014

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 10, 2011

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code MMY·March 17, 2014

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code DXE·October 23, 2012

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORP.·Product code DXE·December 21, 2012

    THROMBUSTER II

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code DXE·January 16, 2019

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024