BEUDAMED
    14 results · 24ms · 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 ×

    General Cutting Contra Handpiece

    FDA 510(k)
    FDA Class 1 ·Dental

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·May 28, 2023

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112533·BARRON VACUUM TREPHINE 8.5MM

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113387·ALIO MICS TRAP KNIFE (BX/5)

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112953·CORNEAL TREPHINE BLADE8.5MM

    GE QUASAR NUCLEAR MEDICINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2024

    COMP RVRS SHLDR GLNSP +6 41MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·August 26, 2022

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014

    M2A-MAGNUM 42-50MM TAPER INSERT-3

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 2, 2013

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021