BEUDAMED
    14 results · 38ms · Sources: EU EUDAMED, US FDA

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    PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054816·Polycarbonate Crowns

    I-PORT ADVANCE

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 3, 2025

    INVERNESS MEDICAL EARLY PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SOFTFORM FACIAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DA VINCI ROBOTICS SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 13, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011

    BARD COMPOSIX KUGEL HERNIA PATCH

    FDA Adverse Event
    Injury ·BARD·Product code FTL·February 21, 2008

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code MFK·November 4, 2024

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·August 1, 2023

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025