BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    BI-LEVEL ASSAYED CARD. DRUG CONT., I,II

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    ACCULIF

    FDA UDI
    Stryker Corporation·07613327067088·SYRINGE PLUNGER O-RING (RED)

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left

    ACUMED

    FDA UDI
    Acumed LLC·10806378041501·.035" Depth Probe

    MEDELA INVIA WOUND THERAPY

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

    EZ CONNECT RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 22, 2012

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 28, 2007

    Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.

    FDA Recall
    Terminated ·Westone Laboratories, Inc.·Product code KMJ·July 13, 2012

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014

    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014