BEUDAMED
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    FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832021970·Crego

    TruLock

    FDA UDI
    Rmo, Inc.·00885797648013·TRULOCK Primer Activated Adhesive Mini Kit (1ea...

    Precisor EXL

    FDA UDI
    Conmed Corporation·30653405051842·Precisor EXL Coated Disposable Biopsy Forceps, ...

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501068·TeWa CB-Type 3050: coated acupuncture needles ...

    TEWA

    FDA UDI
    asia-med GmbH·04251282508388·TeWa CB-Type 3050: coated acupuncture needles ...

    AUDIOSCREENER OAE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ENRAF-NONIUS SONOPULS 190 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·August 6, 2021

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 1+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 25, 2021

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 12, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 24, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·February 18, 2008

    SMR CEMENTED STEM Ø18 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·November 7, 2023

    URETERO-RENO FIBERSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FGB·August 7, 2024

    BrightView SPECT model number 882480 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·April 12, 2017

    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

    BrightView XCT (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 XCT

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

    BrightView XCT , Model Number 882482

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