BEUDAMED
    218 results · 15ms · Sources: EU EUDAMED, US FDA

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

    Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 19, 2013

    PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.

    FDA Enforcement
    Class II ·Terminated·Topcon Medical Laser Systems, Inc·July 31, 2013

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·March 18, 2020

    Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.

    FDA Enforcement
    Class II ·Terminated·Orthosensor, Inc.·October 17, 2018

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.

    FDA Enforcement
    Class II ·Terminated·Orthosensor, Inc.·October 17, 2018

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f) GYN PACK, kit number SMGY46; g) Lithotomy Pack, kit number THLH71C; h) ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA; i) GYN LAPAROSCOPY HPES, kit number WELP67C; j) GYN LAPAROSCOPY HPES, kit number WELP67C-01; k) GYN LAPAROSCOPY HPES, kit number WELP67C-02

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·September 10, 2025

    VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    FDA Enforcement
    Class II ·Ongoing·DRG International, Inc.·January 22, 2025

    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

    FDA Enforcement
    Class II ·Terminated·Penner Mfg Inc·April 1, 2015

    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 17, 2016

    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 20, 2016

    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 29, 2017

    Merge RadSuite software. Radiological image processing system.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·September 14, 2016