BEUDAMED
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    GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517177872·VuePoint Hook, 7mm Laminar

    ORA Retaining Ring

    FDA UDI
    STERNGOLD DENTAL LLC·00841549110139·The ORA Implant Abutment System is a precision ...

    SPEEDPASS DISPOSABLE

    FDA UDI
    Biomet Orthopedics, LLC·00880304405240·

    OsteoVation

    FDA UDI
    SKELETAL KINETICS LLC·00813845020115·OsteoVation QWIK Inject Bone Void Filler

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746099892·DB BKT MASTER 7.0MM LANG UL CEN 018 T+12 A+5 R=0

    Symmetry Surgical®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482142295·FlashPak® Lid, Lid w/Seal, For 9040, Large

    IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VALLEYLAB

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·April 12, 2017

    HYDRATOME RX SPHINCTEROTOME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·November 20, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 30, 2012

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024