BEUDAMED
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    Fusion Black Powder-Free Nitrile Exam Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120496·Guidewire 1.1x150mm Sgl Trocar

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053890·ORTHOS ACCENT LSM 5SGL NDX -10TX22 R

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120472·Guidewire 1.1x150mm Dbl Trocar

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306819957·Neelde Holder, Axial Handle, 3.5mm Shaft, 15cm ...

    TINA-QUANT IGG GEN.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT VERIO FLEX METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 19, 2016

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 19, 2015

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    FDA Adverse Event
    Other ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 29, 2008

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·July 19, 2015

    MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

    FDA Enforcement
    Class II ·Terminated·Mevion Medical Systems, Inc.·July 29, 2020

    MEVION S250i, MEVION S250; Proton Radiation Treatment System

    FDA Enforcement
    Class II ·Terminated·Mevion Medical Systems, Inc.·July 1, 2020

    MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation

    FDA Enforcement
    Class II ·Terminated·Mevion Medical Systems, Inc.·December 2, 2020

    Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017