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

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    DEKNA-LOK MODEL BP1000V2L

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FITLIFE

    FDA UDI
    Respironics, Inc.·00606959004115·FitLife Mask with Headgear, Small, US

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600010·Tray Insert, Level 1

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0600010·Tray Insert 1, Ocata

    Summit Medical

    FDA UDI
    Summit Medical, Inc.·00385640068673·

    Durable BP Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935104902·

    NA

    FDA UDI
    Summit Medical, Inc.·00385640001465·

    PC COATED FLUOROPLASTIC VENT TUBES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    T2 FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code LMF·October 8, 2007

    BA KIT,WE,P37,INL,1',BE,S37,INL,6'

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828188852·BA KIT,WE,P37,INL,1',BE,S37,INL,6'

    GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·April 5, 2013

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·March 10, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQL·June 12, 2008

    GEMSTAR 1.2 MICRON FLTR 244CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 2013

    Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 2, 2016