BEUDAMED
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    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·October 29, 2025

    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·October 29, 2025

    Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·February 16, 2022

    Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)

    FDA Enforcement
    Class II ·Ongoing·Covidien LP·November 6, 2024

    Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.

    FDA Enforcement
    Class II ·Ongoing·Mozarc Medical US LLC·June 17, 2026

    HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).

    FDA Enforcement
    Class II ·Ongoing·Covidien LLC·March 18, 2026

    TourniKwik Tourniquet Set (CFN 79012)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·July 31, 2024

    Enhanced Verify Evaluation Handset (CFN HH90130FA)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·May 7, 2025

    Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·November 19, 2025

    Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·November 19, 2025

    Puritan Bennett 560 Ventilator, PB560, CFN 4096600

    FDA Enforcement
    Class II ·Ongoing·Covidien Llc·September 28, 2022

    AxiEM" Non-Invasive Patient Tracker

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·February 8, 2023

    InPen App, Model/CFN Number: MMT-8061 (Android Users)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·December 24, 2025

    O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.-Littleton·January 8, 2020

    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

    FDA Enforcement
    Class II ·Terminated·Covidien Llc·November 17, 2021

    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·September 10, 2025

    Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021

    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

    FDA Enforcement
    Class II ·Terminated·Ortho Solutions Inc·August 9, 2017

    Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

    FDA Enforcement
    Class II ·Ongoing·Covidien·April 21, 2021

    A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 21, 2026