BEUDAMED
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    PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450214008·

    NAFD 100

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TDK HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 13, 2017

    G7 PPS LTD ACET SHELL 52E

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·April 7, 2025

    NEWPORT

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 16, 2017

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code MMI·May 2, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 15, 2014

    TRIDENT HEMISPHERICAL SOLID BK 56MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·May 12, 2011

    BIPAP AUTOSV ADV

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 10, 2022

    FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER SIZE 3

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·April 7, 2025

    36MM I.D. SIZE E NEUTRAL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 7, 2025

    G7 PPS LTD ACET SHELL 52E

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·April 7, 2025

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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