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

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    ONCENTRA SIMULATION 2.3

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481120848·Attachment System, WP, Tissue Level, Blue Sky B...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450214206·

    Phonak

    FDA UDI
    Phonak AG·07612847868021·Phonak Ambra SP (black)

    THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    ADVISOR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

    ADVISOR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 2, 2013

    DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 15, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011

    BUBBLE CPAP SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 18, 2012

    Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code GAM·February 16, 2006

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018