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

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    Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114209·SILICONE TIP CANNULA 27GA (PK/10)

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A203224150·20mm H x 32mm W x 24mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A203224120·20mm H x 32mm W x 24mm L x 12 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A20322480·20mm H x 32mm W x 24mm L x 8 degrees ALIF

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·October 21, 2008

    T:SLIM G4 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·February 23, 2021

    HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFUSION CATHETER EXTENSION SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDOVIVE SAFETY PEG KITS PULL METHOD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 17, 2008

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·August 11, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013

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

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

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025