BEUDAMED
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    Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.

    FDA Recall
    Terminated ·Chad Therapeutics Inc·Product code BZD·March 25, 2005

    ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MWS·November 16, 2011

    OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code MBI·August 8, 2011

    Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.

    FDA Enforcement
    Class II ·Terminated·Southmedic, Inc.·April 11, 2018

    IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    IMMULITE /IMMULITE 1000 OM-MA (CA125)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LTK·January 2, 2018

    Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·October 9, 2013

    Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code MWS·August 13, 2014

    Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.

    FDA Recall
    Terminated ·Guidant Cardiac Surgery·Product code MWS·December 1, 2006

    Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100

    FDA Recall
    Terminated ·Guidant Cardiac Surgery·Product code MWS·December 1, 2006

    IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LTK·January 2, 2018

    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..

    FDA Enforcement
    Class II ·Terminated·Nakanishi Inc.·October 31, 2018

    ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.

    FDA Recall
    Terminated ·ArthroCare Corporation·Product code MBI·September 30, 2010

    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·September 30, 2020

    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·November 5, 2014

    OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code KOG·August 8, 2011