BEUDAMED
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    TNI MEDICAL AG

    FDA registration
    TNI MEDICAL AG·1 product·🇩🇪 Germany

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    FDA UDI
    TNI medical AG·04059163000774·TNI softFlow 50

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    FDA UDI
    TNI medical AG·04059163000064·Applicator Clinic Std.-Plus softFlow 50

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    FDA UDI
    TNI medical AG·04059163000071·Applicator Clinic Large softFlow 50

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    FDA UDI
    TNI medical AG·04059163000415·TNI softFlow 50

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    FDA UDI
    TNI medical AG·04059163000545·Humidifier Clinic Hygiene Set softFlow

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    FDA UDI
    TNI medical AG·04059163000040·Applicator Clinic Small softFlow 50

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    TNI medical AG·04059163000620·Accessories Set Clinic USA softFlow 50

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    FDA UDI
    TNI medical AG·04059163000057·Applicator Clinic Standard softFlow 50

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    FDA UDI
    TNI medical AG·04059163000408·Protective Cap f. Oxygen Inlet White, softFlow,...

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    FDA UDI
    TNI medical AG·04059163000224·Humidifier Rack Clinic softFlow

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    FDA UDI
    TNI medical AG·04059163000231·Air Bridge Humidifier softFlow

    Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;

    FDA Recall
    Open, Classified ·LeMaitre Vascular, Inc.·Product code LXA·September 2, 2025

    SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR  Radiation Oncology, Martinez, CA.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 11, 2013

    SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 11, 2013

    SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 23, 2013

    SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 23, 2013

    VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics, INc.·Product code QKP·May 3, 2021

    VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany Intended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.

    FDA Recall
    Terminated ·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code MUJ·November 12, 2007

    Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.

    FDA Recall
    Terminated ·Thommen Medical AG Eschenweg 3 Bettlach Switzerland·Product code NDP·April 3, 2019