BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020

    dS Breast 16ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    dS Breast 16ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01

    FDA Enforcement
    Class II ·Terminated·Medtronic·March 22, 2017

    SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01

    FDA Enforcement
    Class II ·Terminated·Medtronic·March 22, 2017

    Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·March 8, 2023

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014

    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

    FDA Enforcement
    Class I ·Ongoing·ICU Medical Inc·May 24, 2023

    Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973

    FDA Enforcement
    Class I ·Ongoing·ICU Medical Inc·May 24, 2023

    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 23, 2014

    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)

    FDA Enforcement
    Class II ·Ongoing·Withings·March 29, 2023