31 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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
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
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
ES0102-45, 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
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
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
AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, 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
AEM Disposable Electrode, Spatula, 35cm, REF ES0301, 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
AEM Disposable Electrode, L-Diamond, 35cm, REF ES0311, 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
AEM Disposable Electrode, J-Hook, 35cm, REF ES0310, 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
AEM Disposable Electrode, Flat J-Hook, 35cm, REF ES0309, 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
AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, 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
AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45, 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
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