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    CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ArgenZ HT+ 98x25 ML B2B

    FDA UDI
    ARGEN CORPORATION, THE·D818130394·Dental porcelain/ceramic restoration kit

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378563·Integra® Jarit® Russian Tissue Forceps, 12", Mi...

    General Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575448555·Broach Handle, Anterior, 40°

    General Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575448562·Broach Handle, Straight

    LCU Hip System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575215546·Surgical instrument handle, non-torque-limiting...

    LCU Hip System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575215553·Surgical instrument handle, non-torque-limiting...

    LCU Hip System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575215539·Surgical instrument handle, non-torque-limiting...

    General Instrument

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575448548·Broach Handle, Extra Offset

    FLUID SAMPLE RETRIEVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMP LK SCR 3.5HEX 4.75X25 ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 24, 2013

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·September 30, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

    1.5MM TI CORTEX SCREW SELF-TAPPING 8MM

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·April 6, 2015

    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany·Product code LXH·September 11, 2024

    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Corp. Hq.)·October 2, 2024

    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·March 19, 2014