BEUDAMED
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    SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    Stamey

    FDA UDI
    COOK INCORPORATED·00827002149243·Stamey Percutaneous Loop T.U.R.P. Suprapubic Ca...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694018807·1.6mm x 10mm Lag Screw

    Guedel Airways (color coded)

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043816103·100MM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000994·1.6mm x 10mm Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694029377·1.6mm x 10mm Screw, Sterile

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694067249·HPS 1.6 x 10mm Lag Screw Sterile Qty 5

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694054461·1.6mm x 10mm Screw Sterile Qty 10

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

    LIVESURE METHAMPHETAMINE SCREEN TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    QAB2A IGM ELISA KIT HRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    CORONAL ROD BENDER-LEFT FOR 5.5MM RODS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXW·April 29, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 13, 2011

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 25, 2008

    Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX UPGRADE, 1.5 HDX, 1.5 HDX ECHOSPEED 16 CH, 1.5 HDX ECHOSPEED 8 CHANNEL, 1.5 HDXT, 1.5 HDXT-16 , 1.5 LX TO HDX 16C FORKLIFT UPG, 1.5 LX TO HDX 8C FORKLIFT UPG, 1.5 T UPGRADE TO HDX, 1.5EXCIT TO HDXT UPG, 1.5T HDX 16 CHANNEL, 1.5T 16CH UPG, 1.5T 6 CH HDX , UPGRADE, 1.5T 8CH HDXT TO 16CH HDXT UPG, 1.5T CRM LX TO HDX UPG, 1.5T ES HDX W/ONCOLOGY PACK, 1.5T EXC.TO HDX UPG, 1.5T EXC.TO HDXT UPG, 1.5T EXCITE HD TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG, 1.5T EXCITE TO HDX UPG. W/ACGD, 1.5T EXCITE TO HDXT UPG, 1.5T EXCITE TO HDXT UPGRADE, 1.5T EX-HDX, 1.5T EX-HDXTWIN, 1.5T HD ES/HS MOBILE, 1.5T HD TO HDX UPG. 1.5T HD TO HDX UPGRADE, 1.5T HD TO HDXT UPG, 1.5T HD TO HDXT UPGRADE 1.5T HDI,1.5T HDI 16CH FIXED, 1.5T HDI 8CH FIXED, 1.5T HDI ECHOSPEED 1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHANNEL 1.5T HDI ECHOSPEED 8 CHANNEL., 1.5T HDI ECHOSPEED 8 CHANNEL, 1.5T HDI ECHOSPEED 8 CHAN¿SO2762285, 1.5T HDI ECHOSPEED 8CH, 1.5T HDI ECHOSPEED MOBILE, 1.5T HDI ECSHOSPEED 8CH, 1.5T HDI TO HDXT UPGRADE, 1.5T HDX, 1.5T HDX - MEIRAV (BREAST), 1.5T HDX 8CM 1.5T HDX ECHOSPD 16, 1.5T HDX ECHOSPEED, 1.5T HDX ECHOSPEED 1.5T HDX ECHOSPEED 16, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNEL, 1.5T HDX ECHOSPEED 16 CHANNELS, 1.5T HDX ECHOSPEED 16CH¿SO2659508, 1.5T HDX ECHOSPEED 16CH-SO2718893, 1.5T HDX ECHOSPEED 32 CHANNEL, 1.5T HDX ECHOSPEED 8 CH, 1.5T HDX ECHOSPEED 8 CHANNEL, 1.5T HDX ECHOSPEED MOBILE 1.5T HDX ECHOSPEED MRI, 1.5T HDX ES, 1.5T HDX ES 16, 1.5T HDX TWINSPEED, 1.5T HDX TWINSPEED 16 CHANNEL, 1.5T HDXT 1.5T HDXT 16CH,1.5T HDXT 16CH CXK4, 1.5T HDXT 16CH ES FIXED 1.5T HDXT 8 CH, 1.5T HDXT 8CH ES FIXED, 1.5T HDXT 8CH UP, 1.5T HDXT ECHOSPEE, 1.5T HDXT ECHOSPEED, 1.5T HDXT ECHOSPEED 16 CH 1.5T HDXT ECHOSPEED 16 CHAN, 1.5T HDXT ECHOSPEED 16 CHANNEL 1.5T HDXT ECHOSPEED 8, 1.5T HDXT ECHOSPEED 8 CHANN, 1.5T HDXT ECHOSPEED 8 CHANNEL, 1.5T HDXT ECHOSPEED 8 CHANNEL , 1.5T HDXT ECHOSPEED 8_CHANNEL, 1.5T HDXT ECHOSPEED MOBILE, 1.5T HDXT ES 8 CH, 1.5T HDXT GS, 1.5T HDXT TWIN, 1.5T HDXT TWINSPEE, 1.5T HDXT TWINSPEED 16 CHAN,1.5T HDXT UPG, 1.5T HDXTID, 1.5T LX HDX, 1.5T LX TO 16 CH HDXT UPG, 1.5T LX TO 16 CHAN, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPG, 1.5T LX TO 16 CHANNEL HDX UPGRADE, 1.5T LX TO 16 CHANNEL HDXT, 1.5T LX TO 16 CHANNEL HDXT UPG, 1.5T LX TO 16CHANNEL HDX U/G2777896, 1.5T LX TO 8 CH HDX UPG, 1.5T LX TO 8 CH HDXT UPG, 1.5T LX TO 8 CHANNEL HDX UP, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG, 1.5T LX TO 8 CHANNEL HDX UPG.827015, 1.5T LX TO 8 CHANNEL HDXT UPG, 1.5T LX TO 8 CHANNEL HDXT UPGRADE, 1.5T LX TO HDXT 1.5T NON LCC4X5X TO HDXT UPGD, 1.5T NON-LCC LX/HRZ 5.5 TO 1.5T HDX, 1.5T SIGNA HDX UPG, 1.5T SIGNA HDXT, 1.5TEXCITE TO HDX UPG W/O A, 1.5TEXCITE TO HDX UPG W/O ACGD, 1.5TNONLCC LXHZ TO HDXT UPG, 1.5TNONLCC LXHZ TO HDXUPGW/ACD, 1.5TNONLCC4X5X TO HDXUPGW/OACD, 1.5TNONLCCLXHZ TO HDXUPGW/O ACD, 1¿5T 8CH HDXT MRI, 1¿5T HDXT, 1¿5T HDXT MRI, 1-5T CRM LX TO HDX , G.W/OACGD, 1-5T CRM LX TO HDXT UPG, 1-5T EXCITE TO 15T EXCITE TO HDX UPG, 1-5T HDI ECHOSPEED 16 CHANNEL, 15T HDI ECHOSPEED 8 CHANNEL, 1-5T HDX ECHOSPEED 16 CHANN, 15T HDX ECHOSPEED 16 CHANNEL, 15T HDX ECHOSPEED 8 CHANNEL, 15T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED MOBILE, 1-5T HDX ECHOSPEED TRANSPORT, 1-5T HDX TWINSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED 16, 1-5T HDXT ECHOSPEED 16 CHAN, 1-5T HDXT ECHOSPEED 16 CHAN-HD16.0, 1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 CHANNEL, 1-5T HDXT ECHOSPEED 16 UPGRADE, 1-5T HDXT ECHOSPEED 8 CHANN, 15T HDXT ECHOSPEED 8 CHANNEL, 1-5T HDXT ECHOSPEED MOBILE, 1-5T HDXT ECHOSPEED RELOCATABLE, 1-5T LX TO 16 CHANNEL HDX UPG, 1-5T LX TO 16 CHANNEL HDXT, 1-5T LX TO 8 CHANNEL HDXT U, 1-5T LX TO

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·October 24, 2018

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018