BEUDAMED
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    SINUS DILATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    EPISPIN

    FDA UDI
    Pajunk GmbH Medizintechnologie·04048223052310·0121351-18

    EpiSpin Lock

    FDA UDI
    Pajunk GmbH Medizintechnologie·14048223009458·EpiSpin Lock Tuohy ...

    EpiSpin Lock

    FDA UDI
    Pajunk GmbH Medizintechnologie·04048223130551·EpiSpin Lock Tuohy with back eye and wings 18G ...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515016668·Crilewood NH, 7"

    NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BIOSTEON CROSS PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code NIM·March 2, 2007

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    GEL KIT

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code FBK·September 19, 2014

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011

    ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018

    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018

    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018