BEUDAMED
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    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489004059·PowerChem Neoprene Exam Gloves, Extra Large

    INTERCURE LTD. RESPI-LOW

    FDA 510(k)
    FDA Class 2 ·Neurology

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964003897·CUSTOM PROCEDURE KIT

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040073230·Carbide Bur RA 701

    TEWA

    FDA UDI
    asia-med GmbH·04251282508951·TeWa 5CB-Type 3013 Speed Pak: coated acupunctu...

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832025244·HUMERAL HEAD TRIAL

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501631·TeWa 5CB-Type 3013 Speed Pak: coated acupunctu...

    LCS TEX FEM STD LT

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code NJL·July 20, 2012

    IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    POSITUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 12, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·February 18, 2011

    PINNACLE MTL INS NEUT36IDX62OD

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD·Product code KWA·February 19, 2008

    SMR REVERSE HUMERAL BODY

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code PHX·May 12, 2023

    SINGLE USE DISTAL COVER

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code FDT·September 4, 2024

    SMR REVERSE HUMERAL BODY

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·October 21, 2022

    SMR REVERSE HUMERAL BODY

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code MBF·October 21, 2022

    AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

    FDA Recall
    Terminated ·Ameriwater Inc·Product code FIP·September 3, 2004

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013