BEUDAMED
    729 results · 10ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CGL·March 26, 2009

    ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·June 9, 2005

    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

    ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

    ABL 800 FLEX series blood gas analyzers containing software version 5.24.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·November 13, 2006

    ABL 700 Series blood gas analyzers equipped with Software Version 3.833.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·November 13, 2006

    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-800 series.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·June 17, 2005

    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·June 17, 2005

    Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series, manufactured from 8/1998 through 11/2004.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code JFP·September 29, 2005

    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code JFP·September 29, 2005

    ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·September 19, 2005

    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·September 19, 2005

    FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 10, 2014

    FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·August 18, 2014

    The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 15, 2015

    Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. 905-671

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·May 22, 2006

    The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·August 15, 2012

    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.

    FDA Enforcement
    Class II ·Terminated·Radiometer America Inc·August 15, 2012

    AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.

    FDA Recall
    Terminated ·Armstrong Medical Services Limited NewBridge Road Wattstown Business Park Coleraine Ireland·Product code CBL·August 5, 2021