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

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

    Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·July 3, 2024

    RAPIDPOINT 500 Blood Gas System

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·December 6, 2023

    RAPIDPOINT 500e Blood Gas System

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·December 6, 2023

    IntelliVue G7m Anesthesia Gas Module, Product Number 866173

    FDA Enforcement
    Class II ·Ongoing·Philips North America·October 9, 2024

    Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Enforcement
    Class II ·Ongoing·DRE Medical Group Inc·July 5, 2023

    SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·July 29, 2020

    Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)

    FDA Enforcement
    Class II ·Ongoing·Draegerwerk Ag & Co. Kgaa·February 7, 2024

    BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·May 6, 2026

    BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·May 6, 2026

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

    FDA Enforcement
    Class II ·Ongoing·LivaNova Deutschland GmbH·December 4, 2024

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

    FDA Enforcement
    Class II ·Ongoing·LONGHORN VACCINES AND DIAGNOSTIC·September 23, 2020

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025