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

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    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613115234·WIRE TWISTER JAWS HAVE TC (USE WITH STERNAL NEE...

    NexxZr™ T / D-100-35-NT-C200-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113313·

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981190491·Interbody, 11mm x 32mm x 12mm, 10 Deg

    WaveForm TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981233341·Interbody, 11mm x 32mm x 12mm, 10 Deg, 3D

    Reef TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981204648·Trial, 11mm x 32mm x 12mm, 10 Deg

    WaveForm TO

    FDA UDI
    Seaspine Orthopedics Corporation·10889981288815·Interbody, 11mm x 32mm x 12mm, 10 Deg, 3D

    MODIFICATION TO E-SCAN XQ

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·December 7, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 30, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·September 8, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 29, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM (REFURBISHED)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 17, 2011

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·June 19, 2014

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·January 17, 2023

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021