BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    SEDECAL X PLUS LP PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111060915·DUAL HEAD STETH 30" PURPLE

    BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLECRANON OSTEOTOMY NAIL

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·April 16, 2013

    KNIGHTSTAR 330

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·June 18, 2008

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·April 12, 2011

    MOZAIK

    FDA Adverse Event
    Injury ·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021

    Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·June 20, 2012