BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    SARNS INFANT ARTERIAL BUBBLE SENSOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    JOBST Relief

    FDA UDI
    BSN MEDICAL, INC.·04042809156935·RELIEF 20-30 MM HG CHAP LEFT OPEN TOE SMALL BEI...

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517645814·PRECEPT Tap, 10.5mm Double Lead Cann

    Pin

    FDA UDI
    ADLER ORTHO SPA·08050507134335·PIN DIAM.3.2mm without self-tapping head

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113806·VISCO CANNULA 30GA ANGLE 8MM

    BIOSPHERE MEDICAL INFUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STERRAD 100S STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·May 9, 2014

    STRATUS® CS STAT FLUOROMETRIC ANALYZER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code JHX·October 24, 2012

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 17, 2010

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 5, 2020

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 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 Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021