BEUDAMED
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    HELENA COLOCHECK

    FDA 510(k)
    FDA Class 2 ·Hematology

    MGB Alert® Chlamydophila Pneumoniae Primer Mix ASR - 48 Reactions

    FDA UDI
    Elitechgroup Mdx LLC·03661540951763·"MGB Alert® Chlamydophila pneumoniae Primer Mix...

    PBN HYSTERO-SALPINGOGRAPHY CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNSPECIFIED BY THE COMPLAINANT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTL·April 3, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2012

    ANALYTICAL D MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 16, 2010

    VG2 CERVICAL

    FDA Adverse Event
    Injury ·LIFENET HEALTH·Product code MQV·June 28, 2023

    MTF ODL, PARALLEL 8MM

    FDA Adverse Event
    Injury ·MUSCULOSKELETAL TRANSPLANT FOUNDATION D/B/A/ MTF BIOLOGICS·Product code MQV·June 28, 2023

    VG2 CERVICAL

    FDA Adverse Event
    Injury ·LIFENET HEALTH·Product code MBP·June 28, 2023

    Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code HGM·September 25, 2008

    STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FWZ·February 14, 2024

    Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Usa, Inc Dallas Distribution·Product code HBB·November 30, 2009

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017

    1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).

    FDA Recall
    Open, Classified ·Westmed, Inc.·Product code BZA·September 27, 2024

    Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.

    FDA Recall
    Terminated ·Musculoskeletal Transplant Foundation, Inc.·Product code HXY·May 27, 2015

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    FDA Recall
    Terminated ·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016

    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

    FDA Recall
    Terminated ·Allen Medical Systems·Product code JEB·October 6, 2017

    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

    FDA Recall
    Terminated ·SunMed Holdings, LLC·Product code CBT·September 8, 2022

    Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

    FDA Recall
    Terminated ·Allen Medical Systems·Product code JEB·October 6, 2017