BEUDAMED
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    SUSTAIN RADIOLUCENT SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700594·McGlamry Metatarsal Elevator 6-3/8" (16cm), bla...

    Up&Up Tampons

    FDA UDI
    TARGET CORPORATION·00834533001131·Multi pack of 34 - 17 Regular/17 Super

    BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)

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

    RADICAL

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·April 16, 2015

    NEXGEN PROLONG LPS - FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER·Product code JWH·April 3, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 5, 2011

    PRECISION

    FDA Adverse Event
    Injury ·ADVANCED BIONICS CORP.·Product code LGW·May 8, 2008

    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

    FDA Enforcement
    Class II ·Ongoing·Quest International, Inc.·September 17, 2025

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013