BEUDAMED
    763 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Ongoing × Clear all

    Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·September 25, 2024

    Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·September 25, 2024

    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·September 25, 2024

    Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·September 25, 2024

    iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

    FDA Enforcement
    Class I ·Ongoing·Medical Depot Inc.·May 21, 2025

    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    FDA Enforcement
    Class I ·Ongoing·Fresenius Kabi USA, LLC·February 12, 2025

    Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

    FDA Enforcement
    Class I ·Ongoing·Cook Incorporated·May 13, 2026

    Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·July 16, 2025

    Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift - Product Code 2040006; 6) Viking XS Mobile Lift - Product Code 2040007; 7) LikoLight Mobile lift - Product Code 2030001. .

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·July 16, 2025

    Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.

    FDA Enforcement
    Class I ·Ongoing·Cook Incorporated·May 13, 2026

    Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

    FDA Enforcement
    Class I ·Ongoing·Respironics California, LLC·July 28, 2021

    Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

    FDA Enforcement
    Class I ·Ongoing·Respironics California, LLC·July 28, 2021

    Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

    FDA Enforcement
    Class I ·Ongoing·Cook Incorporated·May 13, 2026

    Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.

    FDA Enforcement
    Class I ·Ongoing·AVID Medical, Inc.·May 13, 2026

    Halyard CATH LAB kit. Model Number: SACL75AM.

    FDA Enforcement
    Class I ·Ongoing·AVID Medical, Inc.·May 13, 2026

    Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·April 1, 2026

    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·April 1, 2026

    Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.

    FDA Enforcement
    Class I ·Ongoing·AVID Medical, Inc.·May 13, 2026

    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·April 1, 2026

    Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·April 1, 2026