BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517568595·CoRoent Ant TLIF Ti, 10x11x28mm 4°

    Vue PACS

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971041692·PACS WFM SW < 25K EXAMS/YR

    AGXO

    FDA UDI
    Oticon A/S·05707131350237·G500 S, BTE PP 13 2.4G 105 C090 AGXO

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

    LIPOSUCTION CANNULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0992012840·LIPOSUCTION CANNULA MERCEDES STYLE

    Liposuction Cannula

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896108127·Liposuction Cannula Mercedes Style 250 X 5 Mill...

    KHOURI SPATULA 14g x 15cm

    FDA UDI
    The Wells Johnson Company·B458201284000·Cannula, Khouri Spatula, 14g x 15cm on dll

    STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    EASYTRAK GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 12, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 12, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 21, 2022

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 3, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 27, 2014

    GYNECARE TVT OBTURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    UNK - CONSTRUCTS: PLATE/SCREWS

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·July 30, 2020

    UNK - CONSTRUCTS: PLATE/SCREWS

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·July 30, 2020

    UNK - CONSTRUCTS: PLATE/SCREWS

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·July 30, 2020

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016