BEUDAMED
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    QUPID PLUS E.R.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040051174·FILE - Channels PT Platinum - G1 21MM

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717103735·Stainless Steel K Files (Hand), Size # 15, Leng...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036020415·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157282·

    BACT/ALERT MB CULTURE BOTTLE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODULAR PORP AND TORP MODEL TBD

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013

    XENIUM 150 SYNTH HF DIALYZERSYNTHETIC FOR HEMODIALYSIS

    FDA Adverse Event
    Injury ·NIPRO CORPORATION USD·Product code KDI·March 16, 2011

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 28, 2008

    INNOVA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIP·October 22, 2020

    VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012

    FDA Enforcement
    Class II ·Ongoing·Visionsense, Ltd.·November 30, 2022

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014