BEUDAMED
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    MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169679900·SPACER 5001727 CONTROL PTC 6 DEG 17X27

    CAPSTONE CONTROL™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169109650·SPACER 4001727 6 DEG 17X27

    Sonova Brand

    FDA UDI
    Sonova AG·07613389477009·myPhonak Junior app

    HEYER-SCHULTE ROUND SILASTIC BREAST IMPLANT 425/30 CC

    FDA Adverse Event
    MENTOR CORP.·Product code FTR·April 25, 1994

    BUFFLIGHT CLT SURGICAL LASER SYSTEM

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

    ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Immunology

    TROCAR

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·June 5, 2018

    SILVER SOAKER

    FDA Adverse Event
    Malfunction ·I-FLOW CORP·Product code MEB·March 8, 2013

    TEBBETTS FIBEROPTIC SS RETR 9CMX30MM

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FDG·February 25, 2011

    GUIDANT VASOVIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·GUIDANT CARDIAC SURGERY·Product code GEI·February 19, 2008

    HLM TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    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