BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    BRONCHOSCOPY ELBOW

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NexxZr™ T / D-100-14-NT-D400-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113788·

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981200985·Interbody, 11mm x 32mm x 16mm, 8 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981208103·Trial, 11mm x 32mm x 16mm, 8 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981192990·Interbody, 11mm x 32mm x 16mm, 8 deg

    BAYONET NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896021938·BAYONET NEEDLE HOLDER TUNGSTEN CARBIDE TIP ACUT...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613024000·Stevens Tenotomy Scissors, TC, Curved, Overall ...

    SENSEI X ROBOTIC CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL

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

    530G INSULIN PUMP

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

    ASR ACETABULAR IMPLANT 62

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

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·June 17, 2011

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 22, 2024

    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

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024