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

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    DECOMAT A 8666

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Couture Essence

    FDA UDI
    Carolon Company·00078301984039·

    Couture Essence

    FDA UDI
    Carolon Company·00078301920433·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690129844·PS Insert, Size 4 x 13mm

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867058811·UNIVERS FRAC STEM IMPACTOR,SZ 8-10

    SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-CLONMEL·Product code NIQ·December 10, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 17, 2013

    IDENTITY ADX XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

    FDA Enforcement
    Class II ·Terminated·Focus Diagnostics Inc·July 9, 2014

    Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code OCC·May 15, 2014