BEUDAMED
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    MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerPICC Provena SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741202087·Catheter Placement Kit

    Preat

    FDA UDI
    Preat Corporation·00842092170694·ASC NobelActive™/Conical-compatible RP X 9mm No...

    Epredia

    FDA UDI
    RICHARD-ALLAN SCIENTIFIC COMPANY·00673693214384·Cassettes are designed to contain incised tissu...

    REF SHADE

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI250009690·3-OZ REF SH-69 TOOTH SHD COLD CU

    BELLEGLASS HP OPACEOUS DENTIN

    FDA 510(k)
    FDA Class 2 ·Dental

    NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN

    FDA 510(k)
    FDA Class 1 ·Dental

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·May 20, 2022

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013

    HEALIX BR ANCHOR W/ORTHOCORD

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·February 18, 2011

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·February 18, 2008

    ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·KESTRA MEDICAL TECHNOLOGIES, INC.·Product code MVK·November 19, 2025

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 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