BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AGXO

    FDA UDI
    Oticon A/S·05707131261625·H110, BTE 13 WL 100 TC AGXO

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035385·3.5mm x 22mm Locking Screw

    ELATION® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K133552621·ELATION® MB Base Rx 022 UL/5-5 CS-BC HK

    K133532

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 2, 2021

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376545868·SPS FA Self-Tap Screw, 3.5 x 22 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376694993·PROXIMITY FA SELF-TAP SCREW, 3.5 x 22mm

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210166926·Smooth Shaft Polyaxial Screw, 3.5mm x 22mm

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052669·3.5mm x 22mm Smooth Shaft Poly Screw Assm. The ...

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517071887·

    SEDECAL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·February 22, 2026

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·February 22, 2026

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·February 22, 2026

    SYRINGE 50ML S/T LATEX FREE CONFIGURE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 29, 2021

    7 MM EXTENDED LENGTH ENDOSCOPE

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GCJ·May 24, 2013

    WHITE RELOAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 20, 2011

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·August 21, 2008

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022