BEUDAMED
    45 results · 6ms · Sources: EU EUDAMED, US FDA

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    ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-00A-TSO G5S-00C G5S-01A G5S-02A G5S-02C G5S-02-L G5S-04A G5S-05A G5S-05C G5S-06A G5S-06C G5S-08A G5S-08C G5S-10A G5S-10C G5S-11A G5S-11C G5S-12C G5S-13A G5S-14A G5S-15A G5S-17A G5S-17C G5S-19A G5S-23C G5S-29A G5S-29C G5S-31A G5S-31A-SJA G5S-31C-SJA G5S-36A G5S-37A G5S-41A G5S-41C G5S-80A G5S-80A-TSO G5S-80C G5S-80-L G5S-82A G5S-82C G5S-83C G5S-90C

    FDA Enforcement
    Class II ·Ongoing·Zoll Medical Corporation·July 17, 2024

    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

    FDA Enforcement
    Class II ·Ongoing·ZOLL Medical Corporation·March 19, 2025

    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.

    FDA Enforcement
    Class II ·Ongoing·ZOLL Medical Corporation·March 19, 2025

    SQ40S Blood Transfusion Filter

    FDA Enforcement
    Class II ·Ongoing·GVS TM, Inc·January 28, 2026

    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

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

    FDA Enforcement
    Class II ·Ongoing·GS Biomark LLC·December 7, 2022

    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

    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

    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

    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

    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