BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114216·LASIK CANNULA FLATTENED 23GA

    AccelX Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113646·RETROBULBAR NEEDLE 23GA 38MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10

    BIOMET EXTERNAL WRIST PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ST AIA-PACK CA 19-9

    FDA 510(k)
    FDA Class 2 ·Immunology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 14, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR·Product code KSZ·April 28, 2009

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR·Product code KSZ·March 6, 2009

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRS·April 7, 2026

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRS·April 7, 2026

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRS·April 7, 2026

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS INC.·Product code QFG·February 9, 2026

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 10, 2008

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013

    ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 5, 2020

    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