BEUDAMED
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    CLEAR PLASTIC CONNECTING TUBES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750000999·VITROS Immunodiagnostic Products CA 15-3™ Range...

    ACUMED

    FDA UDI
    Acumed LLC·10806378045479·Large Acutrak 2® 4.7 Screws Caddy Lid

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209121809·

    ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

    FDA 510(k)
    FDA Class 2 ·Immunology

    PHYSICA KR

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HRY·January 14, 2025

    UNK AVENIR BROACH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·January 29, 2021

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 8, 2014

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code LRK·October 17, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007

    MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant.

    FDA Recall
    Terminated ·IMTEC Corporation·Product code KKO·July 7, 2009

    Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, lot numbers 44134-01 and 43589-01; the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick; Medline Industries, Inc., Mundelein, IL 60060;

    FDA Recall
    Terminated ·Medline Industries, Inc.·Product code LRO·March 4, 2005

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022