BEUDAMED
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    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    FDA Enforcement
    Class II ·Completed·Materialise USA LLC·August 31, 2022

    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).

    FDA Enforcement
    Class II ·Terminated·Data Innovations, LLC·October 31, 2018

    3 in 1 STI Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    8 in 1 STI Test Kit

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    2 in 1 Trichomonas / Gardnerella Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)

    FDA Enforcement
    Class II ·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026

    Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·October 24, 2012

    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 9, 2025

    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 9, 2025

    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·July 9, 2025

    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.

    FDA Enforcement
    Class II ·Terminated·Lansinoh Laboratories Inc·February 13, 2013

    PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·May 31, 2017

    Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.

    FDA Enforcement
    Class II ·Terminated·Amerx Health Care Corp.·September 24, 2014

    10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    FDA Enforcement
    Class I ·Terminated·EBI Patient Care, Inc.·May 31, 2017

    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    FDA Enforcement
    Class I ·Terminated·EBI Patient Care, Inc.·May 31, 2017

    Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.

    FDA Enforcement
    Class II ·Terminated·Silver Star Brands·November 26, 2014

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40

    FDA Enforcement
    Class II ·Ongoing·Contego Medical LLC·October 22, 2025

    Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.

    FDA Enforcement
    Class II ·Terminated·Brookstone Company, Inc.·January 2, 2013

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 129 IN, 3 CARESITE LADS; Catalog Number: 490225.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025