BEUDAMED
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    BD CTGCTV2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Zodiac

    FDA UDI
    ALPHATEC SPINE, INC.·00844856003408·TI 5.5MM TELESCOPING BRIDGE, 85MM

    Inertia® Pedicle Screw and Deformity Correxxion® System

    FDA UDI
    NEXXT SPINE, LLC·00889929027516·MAC Pedicle Screw, Ø10.5x85 mm

    EUROPA™ Pedicle Screw

    FDA UDI
    MIRUS LLC·00810025483098·Ø10.5 X 85mm EUROPA™ Pedicle Screw

    CAPTIVA SPINE FUSELOX CERVICAL CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONVEY GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DUR MAR 10D LNR 32IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 22, 2008

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 8, 2011

    ATLAS PLUS DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015