BEUDAMED
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    BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PHASEAL PROTECTOR P50J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023

    ArgenZ ST 98x20 ML C4B

    FDA UDI
    ARGEN CORPORATION, THE·D818130197·Dental porcelain/ceramic restoration kit

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450190081·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450286180·

    ONE TOUCH PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·November 20, 2001

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·December 9, 2020

    GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BLACKSTONE POSTERIOR CERVICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VASOVIEW 6 PRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 21, 2013

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·September 30, 2014

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·June 10, 2011

    SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015