BEUDAMED
    23 results · 30ms · Sources: EU EUDAMED, US FDA

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    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132110·Trial, TLIF, 27L OB CRV 7Deg, 11mm

    MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743458·LEVAMED ANKLE SUPPORT SILVER I

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102110·Shaver, Open 11mm

    Invictus

    FDA UDI
    ALPHATEC SPINE, INC.·00811801031564·Modular Tulip Distractor Tip - Short Inline

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023949·PADDLE SPREADER, 11MM

    MAMMARY PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN HEYER-SCHULTE·Product code FTR·April 17, 1998

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0130110·Segmental Rod Reducer, Slim, Assembly

    HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERILE NITRILE POWDER-FREE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 20, 2013

    SJM REGENT HEART VALVE

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL PUERTO RICO, INC. (CS)·Product code LWQ·March 8, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 12, 2008

    ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-

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

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 1, 2025

    PERFORMER INTRODUCER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 23, 2017

    PERFORMER INTRODUCER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·January 23, 2017

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013