BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    FLOSTAT VASCULAR LAB

    FDA 510(k)
    FDA Class 2 ·Radiology

    MLCL Upgrade

    FDA UDI
    Ge Medical Systems Information Technologies, Inc.·00195278940193·Upgrade Kit MLCL V9.0

    ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Gazelle Polypropylene Suture and Delivery Device

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

    RENEW RECEIVER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·February 19, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 18, 2011

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 1, 2014

    COULTER ACT PAK REAGENT KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·September 24, 2014

    COULTER ACT PAK REAGENT KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·May 26, 2015

    COULTER ACT PAK REAGENT KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·May 5, 2015

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code JPA·June 15, 2012

    Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJT·January 28, 2013

    STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGP·March 4, 2020