BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    SOLAR 2 ANATOMIC SHOULDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201503294·Leksell MPS Arc w Counter Scale - ARC WITH SUPP...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257141083·15-20 MFW VITALITY CALF CT CHARC II

    NA

    FDA UDI
    Conmed Corporation·30653405038720·5MM X 43CM CURVED (MARYLAND) TIP MONOPOLAR DISS...

    Toilet Support Arms

    FDA UDI
    Ropox A/S·05707581006562·

    K-WIRE STRYKER 3.2MM X 450MM KIRSCHNER

    FDA Adverse Event
    Malfunction ·Product code LXH·November 2, 2021

    K-WIRE GAMMA Ø3,2X450 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·April 22, 2022

    RESPONSE 2000 CEMENTED HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULPDENT GLAZE

    FDA 510(k)
    FDA Class 2 ·Dental

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·March 14, 2018

    ACRYSOF TORIC

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD.·Product code HQL·April 3, 2013

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·May 9, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 5, 2011

    ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-432. --- The product is distributed sterile in heat-sealed tray and labeled with an expiration date that pertains only to the sterility.

    FDA Recall
    Terminated ·Conmed Corporation·Product code GCJ·October 12, 2006

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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