BEUDAMED
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    Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEM·August 23, 2017

    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.

    FDA Enforcement
    Class II ·Terminated·Encision, Inc.·July 18, 2012

    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 15, 2012

    TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.

    FDA Enforcement
    Class II ·Terminated·Olympus America Inc.·December 11, 2013

    Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882, Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·August 24, 2011

    EM2 NC AEM Monitor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    EM2M NC AEM Monitor, (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    EM2+A NC AEM Monotor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    Encision AEM Suction Irrigation Electrode, L-Hook, REF ES3883, Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·August 24, 2011

    Encision AEM Suction Irrigation Electrode, J-Hook, REF ES3884. Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·August 24, 2011

    Encision AEM Suction Irrigation Electrode, L-Diamond, REF ES3881. Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·August 24, 2011

    Encision ES4107 Disposable AEM Cord, Sterile.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·July 9, 2004

    AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 11, 2004

    AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·January 15, 2003

    Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·August 24, 2011

    ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·April 7, 2011

    ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·April 7, 2011

    ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·April 7, 2011

    ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·April 7, 2011

    ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·April 7, 2011