BEUDAMED
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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

    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

    Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater required or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.0 or greater or 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 3103PK, 9-3/4" curved. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater required or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.0 or greater or 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 3104PK, 9-3/4" angled. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater required or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.0 or greater or 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 PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.

    FDA Recall
    Terminated ·Gyrus Medical, Inc.·Product code GEI·May 15, 2006

    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

    The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray.

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code GCJ·August 3, 2010

    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

    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, 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

    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, 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 Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code LRC·May 24, 2013

    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 Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA22067A. Working element for endoscopic diagnosis and treatment in urological and gynecological applications.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code KNS·December 27, 2011

    Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code KNS·December 27, 2011

    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