BEUDAMED
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    Anti Grinding Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00842180166202·Brain Spatulas, Stainless Steel, Ebonized, Mall...

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 2, 2020

    IPS CaseDesigner

    FDA 510(k)
    FDA Class 2 ·Radiology

    VARELISA HISTONE ANTIBODIES, MODEL 16496

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYRINGE 0.3ML 31G 8MM

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 21, 2021

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 3, 2018

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 2, 2018

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 10, 2014

    NAVISTAR THERMOCOOL

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER·Product code OAD·August 28, 2011

    INOMAX DSIR (DELIVERY SYSTEM)

    FDA Adverse Event
    Other ·IKARIA·Product code MRN·July 17, 2013

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014