BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    MAGNETOM RHAPSODY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Kwart

    FDA UDI
    COOK INCORPORATED·00827002149106·Kwart Retro-Inject Ureteral Stent Set

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159008821·Micro Kitzmiller Clamp

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 27, 2025

    WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC

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

    D/M ONE-SIDED CABLE TENSIONER

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·July 31, 2012

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 23, 2024

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 15, 2024

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 2, 2020

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 11, 2013

    GASTRIC BANDING

    FDA Adverse Event
    Injury ·Product code LTI·February 23, 2011

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER VASCULAR/THIN - 35 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·February 15, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    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

    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