BEUDAMED
    12 results · 21ms · 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 Regulation: Us FDA ×

    LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KETO-DIASTIX®

    FDA UDI
    ASCENSIA DIABETES CARE US INC.·10301932883509·Reagent Strips for Urinalysis: Ketone; Glucose

    NURVO 9000 ENDOCAVITARY COILS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYSMEX R-500

    FDA 510(k)
    FDA Class 2 ·Hematology

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 13, 2025

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 13, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

    TRILOGY ACETABULAR SYSTEM LINER STANDARD LONGEVITY CROSSLINKED POLYETHELNE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWB·July 24, 2008

    WHITE STAR HIGH SPEED VIT CUTTER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

    PIIC CLASSIC UPGRADE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 24, 2024

    WHITE STAR HIGH SPEED VIT CUTTER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

    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