BEUDAMED
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    Stryker Orthopaedics Hip Systems Labeling Update

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VIVIX-S VW

    FDA 510(k)
    FDA Class 2 ·Radiology

    HYPE SCL 4 LATERALIZED CEMENTLESS STEM

    FDA Adverse Event
    Injury ·S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION·Product code LZO·January 17, 2025

    CONFIRM

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code MXC·September 9, 2011

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO

    FDA Adverse Event
    Injury ·BARD SHANNON LTD·Product code OTN·July 18, 2013

    Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

    FDA Enforcement
    Class I ·Ongoing·Percussionaire Corporation·October 9, 2024

    Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

    FDA Enforcement
    Class I ·Ongoing·Percussionaire Corporation·October 9, 2024

    Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

    FDA Enforcement
    Class I ·Ongoing·Percussionaire Corporation·October 22, 2025

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    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