BEUDAMED
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    HS AMICA DEVICES FAMILY

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

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750004454·VITROS Chemistry Products LAC Slides

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053883·ACCENT B/T 5SGL 2ND NDX -10TX18 UL

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120496·Guidewire 1.1x150mm Sgl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120472·Guidewire 1.1x150mm Dbl Trocar

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038542·TRIAL RASP, 10MM X 22MM

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038559·TRIAL RASP, 12MM X 22MM

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038573·TRIAL RASP, 16MM X 22MM

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038566·TRIAL RASP, 14MM X 22MM

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038535·TRIAL RASP, 8MM X 22MM

    PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117

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

    SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    FORCETRIAD ENERGY PLATFORM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·April 17, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 29, 2008

    REPOSITIONING FORCEPS JAW: BALLSPIKE L135MM

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code LXH·March 23, 2017

    VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·September 24, 2025

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 2, 2015

    UNKNOWN DBS LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 2, 2015

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 2, 2015