BEUDAMED
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    S9 VPAP TX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Alpha 1 Acid Glycoprotein RID plate kit

    FDA UDI
    KENT LABORATORIES INC·B1761235·Radial immunodiffusion plate package for Human ...

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376657073·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 11mm

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981040710·Screw - Self-Drilling - 3.5x11mm

    EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2

    FDA 510(k)
    FDA Class 2 ·Radiology

    LITECURE THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 26, 2014

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·June 8, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 20, 2013

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023