BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

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

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376264745·4.0mm Fixed Angle, Self Drilling Screw, Dual Le...

    STILLE Retractors

    FDA UDI
    Stille AB·07332339205560·RETRACTOR STILLE 2 blunt prongs 6 mm 18 cm 7 in

    ZEOS

    FDA UDI
    SANTA BARBARA IMAGING SYSTEMS, INC.·00812231031209·6.5MM HIGH FLOW SHEATH, DOUBLE STOPCOCK

    Accu-Chek Softclix Blood Lancing System

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

    Sterile single use tip cleaner (WK800-S10 , WK800-S20)

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

    ALINITY C CALCIUM2

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CJY·March 5, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    HYLAN G-F 20

    FDA Adverse Event
    Injury ·Product code MOZ·September 6, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2013

    Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego¿ is a needle-free capping device which closes the end of the catheter. The Tego¿ will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 18, 2017