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

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    BioButton System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694022651·FPS 2.7mm 5 Hole Straight Compression Plate

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128915·Femoral Augment, Notched Posterior, Size 1+, 10mm

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619044534·Non-Vented Male Luer Lock Cap

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694076883·FPS 2.7 5 Hole Straight Compression Plate Steri...

    LITHO

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

    MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ADULT COMFORT FLO NASAL CANNULA

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAT·June 27, 2017

    FEMALE NON-VENTED LUER LOCK COVER

    FDA Adverse Event
    Other ·ICU MEDICAL, INC.·Product code FPA·July 12, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 14, 2011

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 21, 2008

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code DWH·July 18, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 14, 2011

    COMFORT FLO HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code OGG·June 27, 2017

    NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 28, 2020

    112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17)241101(30)25(10)4475764 (01)10887709088518(17)250201(30)25(10)4720644. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 28, 2020

    5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709032153(17)241101(30)50(10)4475297; (01)10887709032153(17)250201(30)50(10)4711598. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 28, 2020

    NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111; (01)10840619060906(17)241201(30)100(10)4493213; (01)10840619060906(17)241201(30)100(10)4510900; (01)10840619060906(17)250301(30)100(10)4749152. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 28, 2020

    REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·December 9, 2020