BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    ELECSYS PROBNP IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Q-RAD System

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971051387·Q-RAD SYSTEM/QG-4000-3-R10-T080

    AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 28, 2026

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 10, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 4, 2011

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DXT·May 16, 2008

    CYSTO PACK , Model N. HKCY31A

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018