BEUDAMED
    99 results · 21ms · Sources: EU EUDAMED, US FDA

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    SOFIA DISTAL ACCESS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694026543·MFx Angulated Locking Curved Strut Plate, 2 x 8...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707010982·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 14

    Encompass Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409012978·14mm Cement Restrictor

    DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENS STIMULATOR, MODELS 2800 AND 3000

    FDA 510(k)
    FDA Class 2 ·Neurology

    Magna-FX®

    FDA UDI
    Zimmer, Inc.·00889024024755·

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 25, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 3, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 28, 2011

    OPTIFLUX 200NR DIALYZER FINISHED ASSEMBLY

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·July 15, 2015

    SUMMIT POR TAPER SZ6 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 14, 2014

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 28, 2025

    BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·June 17, 2015

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016

    Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 15, 2016