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

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    ADVANCED UROSCIENCE INJECTION NEEDLE

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673150·LEVAMED STABILI-TRI ANK SUP BLU L III

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950018697·FORCEP STERILIZING UNIVERSAL CURVED 11" 28CM

    NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW

    FDA 510(k)
    FDA Unclassified ·Unknown

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    LINOX S 65

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·March 13, 2013

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·January 27, 2011

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 22, 2008

    HEALON 5

    FDA Adverse Event
    Injury ·PHARMACIA & UPJOHN, FYRISLAND·Product code LZP·March 21, 2002

    ENCOREANYWHERE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 17, 2016

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013