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

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    UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S

    FDA Enforcement
    Class II ·Terminated·NewDeal SA·July 25, 2018

    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 25, 2021

    MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.

    FDA Recall
    Terminated ·Medrad Inc·Product code DXT·May 17, 2010

    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.

    FDA Recall
    Terminated ·Tornier, Inc·Product code KWS·September 19, 2016

    TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S

    FDA Enforcement
    Class II ·Terminated·NewDeal SA·July 25, 2018

    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code MDS·July 15, 2020

    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·December 14, 2016

    ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.

    FDA Recall
    Terminated ·Cardinal Health 303 dba Cardinal Health·Product code FRN·December 19, 2008

    Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065

    FDA Recall
    Terminated ·Freedom Designs Inc·Product code IOR·May 14, 2007

    MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code OZO·May 8, 2017

    MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code OZP·May 8, 2017

    MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code OZO·May 8, 2017

    MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code OZP·May 8, 2017

    Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number :73315 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

    Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    FDA Enforcement
    Class II ·Terminated·Fx Solutions·July 25, 2018

    Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    FDA Enforcement
    Class II ·Terminated·Fx Solutions·July 25, 2018

    Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855, Allez Spine, LLC., Irvine, CA

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code MNI·July 30, 2007

    Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code MNI·July 30, 2007

    Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code MNI·July 30, 2007