13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
FDA Enforcement
Class II
·Terminated·Gyrus Acmi, Incorporated·June 12, 2013
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
FDA Enforcement
Class II
·Terminated·Gyrus Acmi, Incorporated·November 28, 2012
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
FDA Enforcement
Class II
·Ongoing·Gyrus ACMI, Inc.·April 18, 2018
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Olympus Diego Elite Console MDCONS 100
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
FDA Enforcement
Class II
·Terminated·Gyrus ACMI, Inc.·April 24, 2019