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

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    VITADUR-N DENTAL PORCELAIN KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    ABSORB-O-MAT

    FDA UDI
    Biomet Orthopedics, LLC·00880304403314·

    OsteoVation

    FDA UDI
    SKELETAL KINETICS LLC·00813845020085·OsteoVation Impact Bone Void Filler

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112748·BARRON VACUUM PUNCH 7.25MM

    Rampart One Lumbar Interbody Fusion Device

    FDA UDI
    SPINEOLOGY INC.·M7404902105·Rampart One Oblique Spacer

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515227354·Juers Crimper Fcps, serr jaws offset left

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981142131·6.0 Pre Contoured Rod / Cross-Link Caddy

    L CONNECTOR C90J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code LHI·March 10, 2020

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707051624·.022 U6R STD/NC -14T 5 OFF

    OSTEOVATION IMPACT 5CC AND INJECT 5CC

    FDA Adverse Event
    Malfunction ·SKELETAL KINETICS, LLC·Product code GXP·November 25, 2009

    SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RADIANALYZER XPRESS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYMBIQ 3.13 SINGLE C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 2, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·November 10, 2010

    2.4/2.7MM VA-LCP TMT FUSION PLATE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·January 8, 2013

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·November 25, 2019

    OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - 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

    OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - 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, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - 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

    OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - 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 GXP·April 6, 2020