BEUDAMED
    58 results · 15ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Dorsal 1st MTP Fusion Plate... REF 70-0012-S... LOT W58120".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 1st MTP Revision Fusion Plate... REF 70-0018-S... LOT W58121".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Right Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP Revision Fusion Plate... REF 70-0019-S... LOT W58122".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036-S... LOT W58123".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP/MPJ Combo Fusion Plate... REF 70-0037-S... LOT W58148".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·April 29, 2015

    CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·April 29, 2015

    CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·April 29, 2015

    CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·April 29, 2015

    MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·June 13, 2018

    CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·March 6, 2015

    MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

    Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.

    FDA Recall
    Terminated ·Mick Radio Nuclear Instr Inc·Product code IWF·March 30, 2005

    MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

    FDA Recall
    Terminated ·Orthohelix Surgical Designs Inc·Product code HRS·August 22, 2011

    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016

    CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.

    FDA Recall
    Terminated ·iCAD, Inc.·Product code LNH·December 9, 2008

    Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA Inc.·June 29, 2016