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

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    BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JOBST Men's Dress

    FDA UDI
    BSN MEDICAL, INC.·00035664107918·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE EXT...

    REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROSA SURGICAL DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD PHOENIX¿ NID

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LQM·March 9, 2023

    BD LUER SLIP¿ TUBERCULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018

    DELTAPLUSH - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·May 14, 2013

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 23, 2014

    PROWLER SELECT MICROCATHETERS

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code KRA·June 1, 2011

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022

    SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·January 27, 2021

    CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

    FDA Enforcement
    Class II ·Terminated·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·March 7, 2018

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024