BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    LNCS OXIMETRY SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M2376A DEVICELINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUCLEOTOMY INTRADISCAL CATHETER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HOSPITAL NON-VENTED FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CBK·April 5, 2017

    G7 STR MODULAR SHELL INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·August 27, 2024

    G7 STR MODULAR SHELL INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·October 15, 2024

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 29, 2008

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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