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

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    NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139249136·UNITY KNEE™ PS-C INSERT - Size 7T-8F x 22mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450234570·

    OMEGA II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 10, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·August 15, 2008

    ASANTE SNAP INSULIN PUMP SYSTEM

    FDA Adverse Event
    Injury ·ASANTE SOLUTIONS INC.·Product code LZG·August 11, 2014

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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