BEUDAMED
    97 results · 21ms · Sources: EU EUDAMED, US FDA

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    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, 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 Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code ETD·October 17, 2012

    GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010

    Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·October 1, 2008

    Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures.

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code KNY·April 15, 2011

    MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code ETD·January 8, 2010

    Olympus Diego Elite Console MDCONS 100

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC

    FDA Recall
    Terminated ·Gyrus ACMI, Inc.·Product code GEI·March 8, 2019

    Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009

    Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009

    Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code GEI·August 18, 2009