BEUDAMED
    66 results · 13ms · Sources: EU EUDAMED, US FDA

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    Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·July 3, 2013

    PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix2 360 Firm Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix2 360 Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix2 360 Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix 2D Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix2 Helical UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix2 360 UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

    3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.

    FDA Recall
    Terminated ·Product code JWH·March 19, 2010

    Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code IYE·April 19, 2010

    IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQX·May 21, 2010

    Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs).

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code DSA·May 19, 2010

    Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code BRY·April 7, 2010

    SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·July 19, 2010

    CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.

    FDA Recall
    Terminated ·Civco Medical Instruments Inc·Product code ITX·July 20, 2010

    Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STERILE/R Stryker Craniomaxillofacial, Portage, MI. The INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a craniomaxillofacial plating system intended to maintain accurate alignment of bone fractures and osteotomies in the cranium and mid-face.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code HWC·March 5, 2010