BEUDAMED
    17 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 ×

    Infrared Forehead Thermometer, Model BSX976

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113264·SIDEPORT KNIFE 1MM ANGLED (BX/5)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)

    LUCIRA CHECK-IT COVID-19 TEST

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·August 1, 2023

    CHECK-IT

    FDA Adverse Event
    Malfunction ·PFIZER, INC.·Product code QJR·May 8, 2023

    MODIFICATION TO EN-BLOC BIOPSY SYSTEM

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

    CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15

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

    VERSATAP SUTURE ANCHOR

    FDA Adverse Event
    Malfunction ·ORTHO-DESIGN·Product code MBI·September 15, 2025

    TRUE METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·April 28, 2021

    GE HEALTHCARE INFANT WARMER

    FDA Adverse Event
    Injury ·GE HEALTHCARE·Product code FMT·June 25, 2013

    TENDRILL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·August 2, 2011

    WALLSTENT ENTERNAL PROSTHESIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·January 9, 2023

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code PCU·January 9, 2023

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·November 4, 2024

    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