BEUDAMED
    313 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

    FDA Enforcement
    Class II ·Ongoing·PATH·December 24, 2025

    AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

    FDA Enforcement
    Class II ·Ongoing·PATH·December 6, 2023

    SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

    FDA Enforcement
    Class II ·Ongoing·PATH·December 6, 2023

    SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

    FDA Enforcement
    Class II ·Ongoing·PATH·December 6, 2023

    SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

    FDA Enforcement
    Class II ·Ongoing·PATH·December 6, 2023

    AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.

    FDA Enforcement
    Class II ·Terminated·Fenwal Inc·June 19, 2013

    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 11, 2015

    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 27, 2019

    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Microport Orthopedics INC.·June 11, 2014

    L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·October 9, 2019

    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·February 7, 2018

    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Multichem P, Part Code 08P90-10

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025

    Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025

    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·January 16, 2013

    MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·June 11, 2014

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·January 22, 2014

    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·December 5, 2018