BEUDAMED
    25 results · 29ms · Sources: EU EUDAMED, US FDA

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    SpineUs™ System

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Zimmer, Inc.·00889024062184·

    NA

    FDA UDI
    STERILMED, INC.·10888551021623·DRILL BIT QUICK COUPLING

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·00678467507440·Customized 24-Channel for Chemical Disinfection...

    Mui Scientific

    FDA UDI
    H & A Mui Enterprises Inc·10678467505771·24-Channel Customized Esophageal HRM Catheter

    TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KINETDX

    FDA 510(k)
    FDA Class 2 ·Radiology

    CMD 24-1029 PROMADE ELBOW

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDC·September 18, 2025

    ATTUNE PS RP INSRT SZ8 6MM

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code NJL·November 10, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 20, 2015

    ARCOS 17X150MM SPL TPR DIST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

    ARCOS CON SZ C STD 60MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

    RICKHAM RESERVOIR

    FDA Adverse Event
    Injury ·JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A·Product code JXG·October 5, 2016

    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.

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

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code LJS·November 22, 2024

    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

    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.

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

    Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

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

    Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.

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