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

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    BIOTROL RUB-E.I.A. TEST G

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CYSTINE TRYPTIC AGAR W/MALTOSE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RAICHEM CO2 REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CLARION IMPLANT

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·April 25, 2014

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 9, 2010

    5.0CM SHORT ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBE·December 27, 2012

    5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Drip Chamber, Clave, Bag Hanger, REF: CH3240; 18 IN (46 cm) Appx 2.9 ml, Add-On Set w/Spiros, Clave Spike, Clamp, Cap, REF: CH3290; 27" (69 cm) Appx 5.2 ml, Bifuse Add-On Set w/15 Drop Drip Chamber, Spiros w/Red Cap, Check Valve, Vented Cap, Bag Hanger, REF: CH3294; Secondary IV Oncology Kit, REF: CH3322; 30 IN (76 cm) Appx 1.8 ml) Ext Set w/2 Spiros, 2 Red Caps, Clamp, REF: CH3327; 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros w/2 Red Caps, 20 Drop In-Line Drip Chamber, 2 Bag Hangers, REF: CH3373; Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port, REF: CH3397; 45" (114 cm) Appx 5.8 ml, Ext Set w/MicroClave, 2 Clave, Spiros w/Red Cap, 2 Clamps, REF: CH3403; Oncology Kit w/20" (51 cm) Ext Set w/MicroClave, Graduated Connector, Transfer Set w/Clave Additive Port, Spiros, Red Cap, 13mm Vial Spike w/Clave, REF: CH3507; Oncology Kit w/Clave Universal Vented Vial Spike, Spinning Spiros w/Red Cap, REF: CH3546; 22" (56 cm) Add-On 150 ml Burette Set (MicroClave, No Shut-Off), w/Spiros, 2 Clamps, Vented Cap, REF: CH3554; 4.5 IN (11 cm) Appx 0.43 ml, Ext Set, Spiros w/Red Cap, REF: CH3559; Oncology Kit w/Spinning Spiros, C-Clip, Red Cap, REF: CH3581; 5 IN (13 cm) Appx 0.57 ml, Ext Set, Anti-Siphon Valve, Spiros, REF: CH3582; Oncology Kit w/Spinning Spiros w/Red Cap, C-Clip; Priming Cap, REF: CH3589; 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: CH3639; 22" (56 cm) Appx 5.6ml, Ext Set, Trifuse w/4 Clave Clear, Spiros w/Red Cap, 1.2 Micron Filter, 4 Clamps, REF: CH3770; 6.5 IN (17 cm) Appx 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros, Red Cap, REF: CH3771; 47" (119 cm) 50 ml Diluent Set for Channel 2 w/20 Drop In-Line Drip Chamber, 2 Spiros, REF: CH4001; 47" (119 cm) 50 ml Diluent Set For Channel 2 w/Bag Spike w/MicroClave Additive Port, Spiros, REF: CH4009; 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: Z7100; 30" (76 cm) 50 ml Diluent Set for Channel 2 w/Spiros, REF: CH4006; 60 IN(152cm)APPX 0.45ml,SMALLBORE EXT,MicroCLAVE,Spiros, REF: Z7040; 6" (15 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 MicroClave, 3 Clamps, Spiros, REF: Z7151

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020