BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    PRESCOTT'S SURGICAL SPEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Premier Excavators

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783008678·EXCAVATOR DE RC GLICK 2

    SCANLAN® Instruments

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159033236·Scanlan Micro Fcp, fh, bayo sty, 0.3mm str DD t...

    CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 14, 2020

    LOCKING MANDIBULAR RECONSTRUCTION PLATE

    FDA Adverse Event
    Injury ·KARL LEIBINGER MEDIZINTECHNIK GMBH CO. KG·Product code MQN·March 12, 2013

    4 FR D/L POLY PICC WITH SAFETY MI IN UPFT

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·February 24, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 12, 2014

    Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 5, 2021

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024