BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    I-PORT ADVANCE INJECTION PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564030535·Set-Up Pack, Spec Procedure

    One-point Fixation with Force Indicator Pediatrics LUCY

    FDA UDI
    Noras MRI products GmbH·04251269206016·The NORAS OR Head Holder LUCY is used for intra...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1203370·

    PharmaTags

    FDA UDI
    RMAC Surgical, Inc·00754027700176·7 sterile custom medication labels

    READI-STRAND; MODEL PSSTRAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2026

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 20, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITJ·September 26, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 10, 2011

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024