BEUDAMED
    319 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 17, 2024

    VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·July 17, 2024

    Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

    FDA Enforcement
    Class II ·Completed·Trumpf Medical Systems, Inc.·January 6, 2016

    Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765

    FDA Enforcement
    Class II ·Terminated·Bayer Medical Care, Inc.·September 12, 2018

    3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 29, 2018

    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·October 3, 2012

    KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013

    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013

    KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Enforcement
    Class II ·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013

    Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·February 27, 2013

    Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 8, 2021

    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

    ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 10, 2026

    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

    FDA Enforcement
    Class II ·Terminated·Hill-Rom, Inc.·November 9, 2016

    Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: 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 Artis zee floor MN- 10094142 Artis zee biplane MN- 10094143

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 24, 2024

    3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 29, 2018

    Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

    FDA Enforcement
    Class II ·Terminated·Contour Fabricators Inc·October 19, 2016

    Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 5, 2014

    Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 21, 2020

    Artis zee ceiling, Model Number 10094137

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022