BEUDAMED
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    THE NEW FLEXIBLE COLLAPSIBLE CHAMBER

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

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196877·Femoral Impactor Pad large

    Supplies

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746031069·SUPPLIES - IMPRESSION TRAY UPPER MEDIUM PINK 20...

    Impression Tray

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746034985·SUPPLIES - IMPRESSION TRAY UPPER MEDIUM PINK 20...

    Supplies

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746162879·SUPPLIES - IMPRESSION TRAY UPPER MEDIUM PINK 20...

    ORTHOPEDIATRICS 4.5MM PLEO OSTEOTOMY GUIDE

    FDA Adverse Event
    Malfunction ·ORTHOPEDIATRICS CORP·Product code HRS·October 19, 2012

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011861101220·Standard Band, Tooth 44/34, Size 1/Roth 22

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011861101000·Standard Band, Tooth 45-44/34-35, Size 1

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011861101180·Standard Band, Tooth 44/34, Size 1/Roth 18

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197075732·Balfour Side-arm left

    PolypVac Microdebrider (3.3mm and 4.0mm)

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

    D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2010

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 4, 2012

    4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc¿ Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·November 28, 2012

    SmartPath to dStream for 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012