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

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    REUNITE FUSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040009734·Zirlux 16+ D4 100X10

    READERS.COM

    FDA UDI
    FGX INTERNATIONAL INC.·00192304074051·

    READERS.COM

    FDA UDI
    FGX INTERNATIONAL INC.·00192304074020·

    READERS.COM

    FDA UDI
    FGX INTERNATIONAL INC.·00192304074037·

    READERS.COM

    FDA UDI
    FGX INTERNATIONAL INC.·00192304074044·

    MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOVAMETRIX MARQUETTE COMPATIBLE SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3004753838-2018-011451

    FDA Adverse Event
    Malfunction ·February 2, 2018

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-VS·Product code NIM·December 23, 2010

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 19, 2013

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011

    PFC SIGMA/OV/DOME PAT 3PEG, 35

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 11, 2008

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014