BEUDAMED
    51 results · 20ms · Sources: EU EUDAMED, US FDA

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    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

    The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc.·February 12, 2025

    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

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

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

    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

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    FDA Enforcement
    Class II ·Ongoing·Covidien LLC·September 5, 2018

    O-arm O2 Imaging System. Mobile X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.-Boxborough·July 16, 2025

    CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA, Inc·August 16, 2023

    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Navigation, Inc.·November 23, 2022

    AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    FDA Enforcement
    Class I ·Ongoing·SonarMed Inc·April 24, 2024

    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 8, 2025