BEUDAMED
    559 results · 17ms · Sources: EU EUDAMED, US FDA

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    5.0cm Short Attachment

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

    Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

    Bearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

    5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

    Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

    ARCH Leg Positioning System

    FDA Recall
    Terminated ·Innovative Orthopedic Technologies, LLC·Product code BWN·September 13, 2021

    MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011

    MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011

    MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011

    MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011

    MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011

    MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan·Product code GAM·July 20, 2011

    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·December 15, 2015

    VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·July 5, 2014

    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·March 7, 2016

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·December 2, 2014

    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·June 21, 2013

    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

    FDA Recall
    Terminated ·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK 6-22, 4-CHOME, KAN-ON-SHIN-MACHI NISHI-KU HIROSHIMA Japan·Product code IYE·April 17, 2015

    AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, SCS·October 15, 2025