BEUDAMED
    441 results · 13ms · 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 ×

    KION Anesthesia System.

    FDA Recall
    Terminated ·Maquet Inc·Product code BZR·January 11, 2005

    CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses

    FDA Recall
    Terminated ·CAREstream Medical LLC·Product code BZR·May 15, 2018

    O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code BZR·May 14, 2018

    NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (3) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015012, UPN H965700150121, Four-way Stopcock with Rotating Collar, Rx only, Sterile; (4) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015013, UPN H965700150131, Four-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (5) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015015, UPN H965700150151, One-way Stopcock with Collar, Rx only, Sterile; (6) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035002, UPN H965700350021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (7) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035003, UPN H965700350031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (8) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035008, UPN H965700350081, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (9) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035009, UPN H965700350091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (10) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055003, UPN H965700550031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (11) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055008, UPN H965700550081, Three-way Stopcock with Rotating Adapter, Rx only, Sterile; (12) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055009, UPN H965700550091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; and (13) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055017, UPN H965700550171, One-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile.

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·October 6, 2021

    Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular·July 25, 2012

    Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.

    FDA Enforcement
    Class II ·Terminated·Prism Medical Services USA·July 3, 2013

    NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (3) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015012, UPN H965700150121, Four-way Stopcock with Rotating Collar, Rx only, Sterile; (4) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015013, UPN H965700150131, Four-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (5) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015015, UPN H965700150151, One-way Stopcock with Collar, Rx only, Sterile; (6) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035002, UPN H965700350021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (7) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035003, UPN H965700350031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (8) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035008, UPN H965700350081, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (9) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035009, UPN H965700350091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (10) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055003, UPN H965700550031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (11) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055008, UPN H965700550081, Three-way Stopcock with Rotating Adapter, Rx only, Sterile; (12) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055009, UPN H965700550091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; and (13) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055017, UPN H965700550171, One-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code DTL·August 6, 2021

    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.

    FDA Enforcement
    Class II ·Terminated·BTE Technologies, Inc.·July 15, 2015

    Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history, physical examination and imaging studies which demonstrate neural compression using MRI to treat a large annular defect (between 4-6 mm tall and between 6-10 mm wide) following a primary discectomy procedure (excision of herniated intervertebral disc) at a single level between L4 and S1.

    FDA Enforcement
    Class II ·Terminated·Intrinsic Therapeutics, Inc.·August 19, 2020

    VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    FDA Recall
    Terminated ·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008

    Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.

    FDA Recall
    Terminated ·Abbott Molecular·Product code JQW·January 31, 2012

    Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc., Warsaw, The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed. IN; Prod. Nos. 00-2700-965-02 and 00-0965-001-00.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code IKX·July 7, 2008

    JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V, REF 71055451, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JDW·April 13, 2012

    AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706

    FDA Enforcement
    Class III ·Terminated·Tosoh Smd Inc·January 1, 2020

    PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.

    FDA Enforcement
    Class II ·Terminated·Winco Mfg., LLC·March 5, 2014

    Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable headboards; Zimmer Inc., Warsaw, IN; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code IKX·July 7, 2008

    Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.

    FDA Recall
    Terminated ·Prism Medical Services USA·Product code FNG·January 27, 2013

    Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup¿ Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches of Bar Electrodes and each pouch contains 10 electrodes

    FDA Recall
    Terminated ·Nicolet Biomedical Div of Viasys Healthcare·Product code GXZ·April 28, 2006

    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.

    FDA Enforcement
    Class III ·Terminated·Medefil Incorporated·March 12, 2014