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

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    SMART (SMART-D, SMART-DX)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Oticon A/S·05707131256553·NERA, MINIBTE 312 WL 85 SIL

    NC Screw-retained Abutment

    FDA UDI
    BIO CONCEPT Co., Ltd.·06947600381075·

    Freedom Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215027124·

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code JXI·August 24, 2015

    FERRIS POLYMEM STERILE BREAST PAD

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    RELOAD FOR 60MM ECHELON

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021

    ALINITY I AFP REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code LOK·May 5, 2021

    THINLINE

    FDA Adverse Event
    Injury ·GUIDANT ANGLETON/ST. PAUL·Product code NVY·October 1, 2014

    ASPHERE M SPEC 12/14 36 +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 29, 2013

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code JXI·October 24, 2019

    Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·January 15, 2014

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015