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

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    Indigo® Aspiration System – Lightning Bolt Aspiration Tubing

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASO Ankle Stabilizer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357231867·

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114124·CHARLEUS CORTEX EXTR 23GA 16MM PK/10

    OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31

    FDA 510(k)
    FDA Class 2 ·Radiology

    Z-800F

    FDA Adverse Event
    Malfunction ·ZYNO MEDICAL, LLC·Product code FRN·March 31, 2026

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 16, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 12, 2013

    Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G

    FDA Enforcement
    Class II ·Ongoing·Apellis Pharmaceuticals, Inc.·October 11, 2023

    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·July 17, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025