BEUDAMED
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    NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040064594·MOLAR BAND LR 2ND 32 (2)

    Integra®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780088370·Integra® Netterville Long Elevator

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707045920·ADAMS CLASPS SIZE 12MM

    Claymount

    FDA UDI
    Varex Imaging Nederland B.V.·08718755000757·x-ray beam-limiting device, to restrict the dim...

    Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00827002447806·Entuit Gastrostomy BR Balloon Retention Feeding...

    BIPOLAR COAGULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401

    FDA 510(k)
    FDA Class 1 ·Dental

    CODEMASTER XL+

    FDA Adverse Event
    Malfunction ·AGILENTTECHNOLOGIES, INC·Product code LDD·March 20, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 15, 2011

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 10, 2008

    An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022