BEUDAMED
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    SUGLUE-10

    FDA 510(k)
    FDA Class 2 ·Dental

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037301210·HUMELOCK II LONG STEM TA6V SIZE 08 LG200 mm CEM...

    SCISSORS OPER CRV S/S 5"

    FDA UDI
    W.H. Holden, Inc.·D9281105080·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K1100080·Tray Insert

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100080·Tray Insert

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100080·Tray Insert 1, Cosmolock, Arcamed

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K1100080·Tray Insert, Level I

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981318529·Modular Trial, 20x17x8mm, 7 Deg Lordosis

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·September 10, 2014

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SE DUAL CHANNEL INFUSION PUMP

    FDA Adverse Event
    Injury ·CAREFUSION CORP.·Product code FRN·April 24, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·September 23, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 1, 2011

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 8, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 6, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 26, 2021

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024