BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    Acucy® Influenza A&B Test with the Acucy® 2 System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LCP

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982166104·3.5MM LCP PROXIMAL HUMERUS PLATE 4H HEAD/8H SHAFT

    Tyber Medical

    FDA UDI
    Tyber Medical, LLC·M695502P241188S1·PLIF 24mm x 8mm x 11mm x 8 °, TyPEEK, Sterile

    Tyber Medical

    FDA UDI
    Tyber Medical, LLC·M695302P241188S1·PLIF 24mm x 8mm x 11mm x 8 °, PEEK, Sterile

    MICRODENT GENIUS IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HWE·December 30, 2025

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HWE·December 30, 2025

    ACCU-CHEK MULTICLIX LANCETS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code FMK·November 20, 2008

    INNOVA 2000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·August 17, 2011

    COMPREHENSIVE PRIMARY STEM 12MM MINI

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBF·July 22, 2013

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HWE·January 20, 2026

    ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; 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

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 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