BEUDAMED
    82 results · 19ms · Sources: EU EUDAMED, US FDA

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    Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08

    FDA Recall
    Open, Classified ·Medivance Inc.·Product code DWJ·June 27, 2024

    TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NAW·July 23, 2021

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Recall
    Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015

    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.

    FDA Recall
    Terminated ·Product code NAW·February 27, 2013

    TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NAW·July 23, 2021

    TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion 447 March Road Ottawa Canada Ontario·Product code NAW·February 24, 2009

    GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·March 25, 2011

    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    FDA Recall
    Open, Classified ·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020

    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.

    FDA Recall
    Terminated ·Sequal Technologies Inc·Product code CAW·October 1, 2009

    Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, Increased Stamina, Improved Sleep, Relief of Stress and Anxiety. Portable Oxygen Delivery System: 98%+ pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 5 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Refill powders have a 2 year shelf life. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. Operating Instructions xxx, Directions: xxx, Caution: xxx, Applications: This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA 30024.

    FDA Recall
    Terminated ·System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140·Product code CAW·May 1, 2003

    HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184. The IOH 200 Homefill is an electromechanical, prescription device designed for use in the home. Its intended function and use is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill cylinders for the patients personal ambulatory use.

    FDA Recall
    Terminated ·Invacare Corporation·Product code CAW·January 11, 2011

    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

    FDA Recall
    Terminated ·Caire, Inc.·Product code CAW·November 21, 2019

    PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code GAW·May 7, 2018

    PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code GAW·May 7, 2018

    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

    FDA Recall
    Open, Classified ·DeVilbiss Healthcare LLC·Product code CAW·September 19, 2022

    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

    FDA Recall
    Open, Classified ·DeVilbiss Healthcare LLC·Product code CAW·March 9, 2023

    JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

    FDA Recall
    Open, Classified ·JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD No·Product code CAW·December 9, 2024

    Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002

    FDA Recall
    Terminated ·Pacific Consolidated Industries LLC·Product code CAW·September 8, 2007

    NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012