108 results
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16ms
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Sources: EU EUDAMED, US FDA
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 Recall
Terminated
·Encision, Inc.·Product code GEI·June 15, 2012
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
ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
FDA Recall
Terminated
·Encision, Inc.·Product code GEI·April 7, 2011
AEM Disposable Electrode, L-Wedge, 45cm, REF ES0312-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
FDA Recall
Terminated
·Encision, Inc.·Product code GEI·April 5, 2010