BEUDAMED
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    RANDOX PREALBUMIN

    FDA 510(k)
    FDA Class 1 ·Immunology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810006611·Gates Glidden Drills RA 32mm

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040066024·Gates Glidden Drills RA 32mm

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092117224·NobelBiocare™ Tri-Lobe-compatible WP 4.5mm Enga...

    CRANIALMAP

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327327212·CRANIALMAP PLANNING

    MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 2, 2025

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

    HOLDING SLEEVE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·August 26, 2021

    PRECISION SPECTRA

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 11, 2017

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 12, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 16, 2011

    AUTOCAT 2 WAVE GERMAN

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·February 15, 2008

    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, 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

    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017

    BrightView SPECT, Model Number 882480

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

    BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018