BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    HNC-127 NEUROVASCULAR ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673150·LEVAMED STABILI-TRI ANK SUP BLU L III

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056462·Zirlux Multi Anterior B1,98.5X22

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673198·LEVAMED STABILI-TRI ANK SUP BLU R III

    G-aenial™

    FDA UDI
    Gc America Inc.·D0470123531·G-aenial Univ. Injectable Unitip B1

    ELECSYS CA 15-3 CALCHECK

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MED-LOGICS DISPOSABLE ALK TUBING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    IPC® STYLUS TRANSNASAL BUR

    FDA Adverse Event
    Death ·MEDTRONIC XOMED INC.·Product code ERL·February 4, 2015

    T-SLING

    FDA Adverse Event
    Injury ·HERNIAMESH S.R.L.·Product code PAH·March 7, 2013

    ACCU-CHEK PERFORMA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·March 9, 2011

    FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS.

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL·Product code DYB·February 12, 2008

    COMBIHESIVE 2S WFR CVX 19/45MM(1X5PK)CEU

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 30, 2020

    COMBIHESIVE 2S WFR CVX 19/45MM(1X5PK)CEU

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 30, 2020

    COMBIHESIVE 2S WFR CVX 19/45MM(1X5PK)CEU

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 30, 2020

    COMBIHESIVE 2S WFR CVX 19/45MM(1X5PK)CEU

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·April 30, 2020

    ENCOREANYWHERE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 17, 2016

    Inserter for Titanium Elastic Nails (TEN), orthopedic device

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·October 21, 2015

    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

    Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 18, 2015

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026