BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Hand Trauma Threaded Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PQ Autoclave Pouches (4-1/4" x 12") Clear Film

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724P2309081·Pk. of 200

    Zavation

    FDA UDI
    Zavation LLC·00197157002923·CIF 14x18, 9 deg, -08

    DISPOSABLE SILICONE FOLEY CATHETER

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

    DEROYAL SURGICAL DRAPES BACKTABLE COVER

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·May 29, 2024

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·October 23, 2024

    ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·March 12, 2024

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 30, 2025

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 23, 2025

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020