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

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    SOL-CARE IV Bag Safety Connector

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    Synthes GmbH·10886982144645·3.0MM CANNULATED SCREW LONG THREAD/32MM

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF2027320·3.0mm Cannulated Screw, Long Thread, 32mm

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2027320·3.0mm, Cannulated Screw, Long Thd., 32mm

    STRYKER NAVIGATION SYSTEM - ENT MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    INFANT/CHILD REDUCED ENERGY ELECTRODES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAW·October 16, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    DURAN ANCORE RING

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021