BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704265835·

    MDMC-12133

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCUSOL DIALYSIS SOLUTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code MEQ·November 10, 2014

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 18, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013

    RAYONE TORIC

    FDA Adverse Event
    Malfunction ·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·July 31, 2024

    VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.

    FDA Enforcement
    Class II ·Terminated·Vortran Medical Technology 1, Inc·May 24, 2017

    PKG, BABCOCK FORCEPS, P/N 0250080241. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 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