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

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    Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)

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

    Ignite RF System

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

    Osteotomy Wedge System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSAONE

    FDA Adverse Event
    Malfunction ·DAVIS & GECK CARIBE LTD·Product code GCJ·September 30, 2025

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·July 2, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    PINNACLE MTL INS NEUT40IDX60OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 19, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 30, 2013

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·May 9, 2017

    VERSAONE

    FDA Adverse Event
    Malfunction ·DAVIS & GECK CARIBE LTD·Product code GCJ·July 15, 2024

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·December 21, 2022

    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012