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

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    POST SURGICAL KIT/POST BIOPSY KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399003690·BUR GUARD, LONG, FOR 2130-000 Drill Module

    ZAVATION

    FDA UDI
    Zavation LLC·00842166151611·WHITNEY 13mmx15mm , 0deg , 11mm

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756965132·PERI/GYN PACK

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93079100111C0·Frazier Suct Tube 11fr - 8" from Bend

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100110·Tray Insert, Rod Connectors

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100110·Tray Insert 4, Cosmolock, Arcamed

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M9307910011180·Frazier Suction Tube 11FR 8" from Bend

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867134621·HUMERAL STEM 11MM

    TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 10, 2010

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 24, 2014

    MICRUSFRAME18 8MM X 30CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 20, 2020

    Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    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