BEUDAMED
    25 results · 28ms · Sources: EU EUDAMED, US FDA

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    TxTi IBF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304270688·

    AVAMAX VERTEBRAL BALLOON

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    MAINFRAME 8252001IP RESPONSE 2.0 W/INCRE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code IKN·June 21, 2013

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 28, 2011

    ZOLL SMART BATTERY

    FDA Adverse Event
    ZOLL MEDICAL CORPORATION·Product code MOQ·August 7, 2008

    E1 VNGD AS TIB BRG 10X63

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 8, 2021

    BIOMET CC CRUCIATE TRAY 63MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 8, 2021

    TPRLC 133 T1 PPS HO 11X142MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·April 1, 2025

    TPRLC 133 MP TYPE1 PPS HO 17.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·April 1, 2025

    TPRLC 133 FP TYPE1 PPS SO 4.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·April 1, 2025

    TPRLC XR MP T1 PPS 15X115MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·April 1, 2025

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026