5 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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GENICON EZEE Retrieval, sterile, Rx only.
FDA Recall
Terminated
·Genicon, Inc.·Product code GCJ·July 19, 2017
GENICON EZEE Retrieval, sterile, Rx only.
FDA Enforcement
Class II
·Terminated·Genicon, Inc.·March 28, 2018
Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions made for positioning the laparoscopic cannulas or ports.
FDA Recall
Terminated
·Genico, Inc., dba Genicon·Product code GEA·September 25, 2008
Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-010-005, 10MM (Foreign Distribution Only). A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.
FDA Recall
Terminated
·Genico, Inc., dba Genicon·Product code GCY·May 8, 2008
Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage.
FDA Recall
Terminated
·Genico, Inc., dba Genicon·Product code GCY·May 8, 2008