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

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    MEDITHERM MED2000

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134

    QUASAR

    FDA UDI
    Modus Medical Devices Inc·G34350033320·RESP-Offset Cedar Insert with Solid Tumour (dri...

    SCANLAN® Legacy Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159033380·TI Legacy NH FH W/RAT 7" STRM

    QUASAR

    FDA UDI
    Modus Medical Devices Inc·G34350033320150·Offset Cedar Insert with Solid Tumour (15 mm) -...

    QUASAR

    FDA UDI
    Modus Medical Devices Inc·G34350033321000·RESP-Offset Cedar Insert with Solid Tumour (dua...

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDL·March 3, 2014

    CONSERVE(R) PLUS SPIKED CUP

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code KWA·March 3, 2014

    NOGA CARDIAC NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EEG SPIKE AND EVENT DETECTOR MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    TECNIS SIMPLICITY

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·December 13, 2024

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    2520274-2013-10938

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code MNI·February 28, 2013

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 1, 2011

    STERRAD NX STERILIZATION SYSTEM

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 27, 2008

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024