BEUDAMED
    18 results · 30ms · Sources: EU EUDAMED, US FDA

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    OnePacs System

    FDA 510(k)
    FDA Class 2 ·Radiology

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741814600·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674181460060·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1814600·18mm H x 14mm W x 60mm L x 0 degrees XLIF

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361978·Integra® Miltex® Stevens Tenotomy Scissors, 4-1...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X18146080·18mm H x 14mm W x 60mm L x 8 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X181460120·18mm H x 14mm W x 60mm L x 12 degrees XLIF

    Regatta

    FDA UDI
    Seaspine Orthopedics Corporation·10889981158569·Lateral Implant, 18mm x 14mm x 60mm, 0 Deg

    Regatta

    FDA UDI
    Seaspine Orthopedics Corporation·10889981158583·Lateral Implant, 18mm x 14mm x 60mm, 15 Deg

    Regatta

    FDA UDI
    Seaspine Orthopedics Corporation·10889981158576·Lateral Implant, 18mm x 14mm x 60mm, 10 Deg

    TDS ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    LOCI 8 CALIBRATOR, MODEL KC 646

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    54 CM BIPOLAR LEAD

    FDA Adverse Event
    Injury ·GREATBATCH MEDICAL·Product code DTB·June 14, 2013

    EQUASHIELD

    FDA Adverse Event
    Malfunction ·EQUASHIELD MEDICAL LTD.·Product code LHI·July 19, 2011

    XP-XP Tibial Tray - Interlok 73 mm Item # 195756

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014