BEUDAMED
    51 results · 12ms · Sources: EU EUDAMED, US FDA

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    Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FMI·July 10, 2017

    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code OLO·April 11, 2014

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    FDA Recall
    Terminated ·Integra Burlington MA, Inc.·Product code GYC·March 18, 2013

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code KKX·July 19, 2013

    Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code HSX·June 4, 2014

    Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code HSX·June 4, 2014

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    FDA Recall
    Terminated ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020

    Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001

    FDA Recall
    Terminated ·Harvard Clinical Technology·Product code MEA·November 3, 2004

    Stryker PainPump1 Base Kit; Product number 500-100-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEA·February 3, 2006

    LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.

    FDA Recall
    Terminated ·Hospira Inc.·Product code MEA·March 8, 2013

    Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001

    FDA Recall
    Terminated ·Harvard Clinical Technology·Product code MEA·November 3, 2004

    Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEA·February 3, 2006

    Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code MAA·March 31, 2003

    Baxter PCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code MEA·December 21, 2005

    Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an accessory for these pumps under Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403. Electri-Cord AC Power Cords are accessories for use with the CADD-Solis Ambulatory Infusion Pump. These power cords allow users to run the pump via AC power rather than battery power. The CADD-Solis pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code MEA·January 27, 2010

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Recall
    Terminated ·Hospira Inc.·Product code MEA·March 8, 2013

    Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.

    FDA Recall
    Terminated ·Danatech Medical Systems Inc·Product code MAA·December 5, 2003

    Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code MAA·March 31, 2003

    Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments, Kalamazoo, MI.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEA·February 1, 2010

    LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a wide range of clinical settings that includes but is not limited to the following: medical, laboratory/delivery/post-partum, burn unit, surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), pediatrics.

    FDA Recall
    Terminated ·Hospira Inc.·Product code MEA·March 8, 2013