BEUDAMED
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    FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Keystone HB VPS

    FDA UDI
    Keystone Industries·H66860817121·HB VPS Light Body Reg Set

    PMMA disc

    FDA UDI
    Dentsply International Inc.·D00180817120·

    Stamey

    FDA UDI
    COOK INCORPORATED·00827002148123·Stamey Percutaneous Loop Suprapubic Catheter Set

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180505342·Osteotome, Straight, 12mm

    LATEX EXAMINATION GLOVES- POWDER FREE, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    3D ACTIVETRAC

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 17, 2020

    NDEHP PRIMARY PLUM PREPIERCED Y

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013

    adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

    FDA Enforcement
    Class II ·Terminated·TZ Medical Inc.·June 5, 2013

    BD IV SYRINGES 5 ML

    FDA Adverse Event
    Other ·BD·Product code FMF·September 2, 2016

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 12, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·July 25, 2008

    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

    FDA Enforcement
    Class II ·Terminated·Progressive Medical Inc·May 29, 2013

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.

    FDA Enforcement
    Class II ·Terminated·Unimed Surgical Products, Inc.·May 29, 2013

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018