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

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

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A

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

    microTargeting" Drive System, Product Number MT-DS-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 15, 2020

    microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number MT-DS

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D; i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F; j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F; k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K; l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F; m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C; n. ROBOTIC PACK-LF, Model Number: DYNJ904250G; o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G; p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I; q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I; r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    The ICS CHARTR EP 200

    FDA Enforcement
    Class II ·Terminated·GN Otometrics·October 30, 2019