BEUDAMED
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    BELLEGLASS HP TRANSLUCENT DENTIN

    FDA 510(k)
    FDA Class 2 ·Dental

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741102899·Catheter Placement Kit

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489004066·PowerChem Neoprene Exam Gloves, Extra Extra Large

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040043875·Tofflemire Matrix Retainer

    TEWA

    FDA UDI
    asia-med GmbH·04251282509583·TeWa CJ-Type 1615: coated acupuncture needles ...

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282502263·TeWa CJ-Type 1615: coated acupuncture needles ...

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 30, 2022

    ENTEC REFLEX WAND 55, MODEL E4055-00

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

    SYNERGY VLS CAP NUT MODELS 2206, 6102

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AIRWAY MOBILESCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code EOQ·October 10, 2024

    MICRO OSCILLATING SAW WITH XL BLADE MOUNT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·March 12, 2013

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·February 24, 2011

    MALLINCKRODT

    FDA Adverse Event
    Injury ·HENEQUEN·Product code BTO·February 21, 2008

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 17, 2022

    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016