BEUDAMED
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    MAGNETOM Avanto Fit

    FDA 510(k)
    FDA Class 2 ·Radiology

    KeyPrint

    FDA UDI
    Keystone Industries·H66842201511·KeySplint Soft Pink 1kg

    Misc

    FDA UDI
    ORMCO CORPORATION·00889989074819·SPACER RD HARD 051 X 1MM PKG50 2-1012

    THUMB RING SKIN HOOK

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896026476·THUMB RING SKIN HOOK SMALL SHARP TIPS

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5

    MST/Dewey .9mm A1 Phaco Tip 15deg

    FDA UDI
    MICROSURGICAL TECHNOLOGY, INC.·00844685000234·

    NEBULAE I

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    UD-1000 ULTRASONIC A/B SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 15, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 3, 2014

    QUADRA ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·November 27, 2019