BEUDAMED
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    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978959030·DISTRACTOR 9091214 14MM OBLIQUE 8 DEG

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065869·EXTRAORAL ELASTICS 3/16" 14 oz

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198987·AK3 Congruent Insert Trial Size 2, 14mm

    NA

    FDA UDI
    STERILMED, INC.·10888551018036·BUR CARBIDE MICRO SIDE-CUTTING TAPERED MEDIUM 6...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450239032·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450241332·

    CONMED

    FDA UDI
    Conmed Corporation·10845854003176·SIDECUTTING BUR, MEDIUM, STRAIGHT, CARBIDE, 2 X...

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CYCLONE ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 4, 2026

    PANORAMA CENTRAL STATION W/ TELEPACK

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 20, 2011

    PREMICATH

    FDA Adverse Event
    Malfunction ·VYGON USA·Product code LJS·October 9, 2020

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·November 20, 2013

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018