BEUDAMED
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    BLOM-SINGER DUCKBILL VOICE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    0800,IPS1,08,N,U,AU,(2) LT,ATW

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828153287·0800,IPS1,08,N,U,AU,(2) LT,ATW

    ACUMED

    FDA UDI
    Acumed LLC·10806378042997·MTP Reamer Concave 10mm With QR

    RUNTHROUGH NS EXTENSION WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO ENVOY PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Death ·DATASCOPE CORP·Product code DSP·May 14, 1998

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·February 11, 2014

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 7, 2007

    RUNTHROUGH NS

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018

    RUNTHROUGH NS

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021