BEUDAMED
    36 results · 14ms · 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 FDA Recall × Status: Open, Classified × Clear all

    Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code JKA·September 6, 2023

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Recall
    Open, Classified ·Stryker Howmedica Osteonics Corp.·Product code MEH·April 30, 2012

    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·August 13, 2025

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

    Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

    FDA Recall
    Open, Classified ·IPG Medical Corporation·Product code GEX·May 5, 2026

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·April 1, 2025

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021

    Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JOJ·May 25, 2022

    Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FPO·May 12, 2021

    myQA iON; Article Number: MQ10-000;

    FDA Recall
    Open, Classified ·IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·April 1, 2025

    Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·October 19, 2023

    Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·October 19, 2023

    Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024