BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SeaSpine Spacer System - Pacifica

    FDA UDI
    Seaspine Orthopedics Corporation·10889981089443·Long Bullet Distractor, 17mm

    AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAYDENT SW

    FDA 510(k)
    FDA Class 2 ·Dental

    SM104 MSERIES W5TH WHLOBS3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 29, 2013

    S-ROM M HEAD 36MM +9

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code JDI·December 17, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024