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

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    ELECTRODE FOR NEUROLOGICAL SURGERY 2111

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809916494208·Long-arm Multi-Axial Cannulated Screw, Ø5.0 x 3...

    NA

    FDA UDI
    Zimmer, Inc.·00889024102392·

    HAYDAY IRRIT-EASER WAND

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DISPOS. ANESTHESIA FACE MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NA

    FDA UDI
    Zimmer, Inc.·00889024074613·

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·October 24, 2012

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·September 13, 2010

    PKG, 5MM SHAFT, NEEDLE HOLDER CURVED LEFT 45CM, P/N 0250080589 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 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