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

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    DRAINAGE CATHETERS W/A DISSOLVABLE TIP

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

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885554006087·SOD HOOK PROBE HEAVY 3MM W/30

    OsteoVation

    FDA UDI
    SKELETAL KINETICS LLC·00813845020047·OsteoVation EX Impact Bone Void Filler

    Ring Curette

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896119987·Ring Curette Blunt

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code HSD·July 14, 2020

    NORMAL SALINE PREFILLED FLUSH

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE COMPASS·Product code FOZ·December 22, 2000

    EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BCI WW1021 PC APPLICATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·December 15, 2009

    2008K HEMODIALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·May 2, 2014

    SAGITTAL BLADE

    FDA Adverse Event
    Malfunction ·STRYKER IRELAND LTD.·Product code GFA·October 22, 2010

    INFUSOMAT SPACE - US VERSION

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·November 20, 2012

    OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Osteomed, LLC·June 10, 2020

    OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    FDA Recall
    Terminated ·Osteomed, LLC·Product code MQV·April 2, 2020

    OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020

    Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

    FDA Enforcement
    Class II ·Ongoing·Scientia Vascular, Inc.·March 22, 2023

    OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Recall
    Terminated ·Skeletal Kinetics, Llc·Product code MQV·April 6, 2020