BEUDAMED
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    Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.

    FDA Enforcement
    Class II ·Ongoing·Activbody, Inc.·December 22, 2021

    Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 2, 2014

    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

    FDA Enforcement
    Class II ·Ongoing·Teleflex Medical·November 27, 2019

    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·August 21, 2019

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    EasyFuse Dynamic Compression System Instrument Pack

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·April 6, 2022

    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·March 2, 2016

    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    FDA Enforcement
    Class III ·Terminated·Oxford Immunotec·September 23, 2020

    Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

    FDA Enforcement
    Class III ·Terminated·Oxford Immunotec·September 23, 2020

    MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·January 28, 2026

    MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·January 28, 2026

    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 8, 2015

    MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·January 28, 2026

    MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·January 28, 2026

    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics·October 23, 2013

    A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

    FDA Enforcement
    Class II ·Ongoing·Genicon, Inc.·November 11, 2020

    WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·November 15, 2017