BEUDAMED
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    KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020911·INTRG WHISP ROTH CUS HK0T +11A 018 UR

    TSI

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215004538·

    PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM

    FDA Adverse Event
    Malfunction ·GUIDANT CARDIAC SURGERY·Product code GCJ·October 28, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 19, 2011

    OCTRODE

    FDA Adverse Event
    Malfunction ·ST JUDE MEDCIAL - NEUROMODULATION·Product code LGW·July 12, 2013

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 12, 2024

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 18, 2018

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020