BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704285888·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128748·Revision Fluted Offset Stem 16mm x 150mm x 4mm

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221117922·3M™ Victory Series™ Second Molar Bands, 955-164...

    PICCOLO BASIC METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·October 22, 2020

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·November 3, 2020

    ENZYNATIC TRIGLYCERIDES REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TUBE DECLOGGER

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

    LIBERTY POSTERIOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 29, 2014

    CAPSURE SP 4024

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 11, 2013

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 15, 2014

    Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·May 3, 2023

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015