BEUDAMED
    39 results · 31ms · Sources: EU EUDAMED, US FDA

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    NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WIZAIR COMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 17, 2026

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 3, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 3, 2011

    EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.

    FDA Enforcement
    Class II ·Terminated·ArthroCare Medical Corporation·July 1, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 8, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 17, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 25, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·November 6, 2014

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 9, 2015

    INRATIO2 PT MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 28, 2015