BEUDAMED
    4 results · 12ms · Sources: EU EUDAMED, US FDA

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    Dr¿ger Perseus A500 Anesthesia Workstation

    FDA Enforcement
    Class I ·Ongoing·Draeger Medical, Inc.·April 24, 2024

    MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KXS 670G V6.3 SF MG CLIN IS;¿ PUMP MMT-1741KXS 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1742KX 670G V6.1 MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN SLO;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 MM;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 EU MM;¿

    FDA Enforcement
    Class II ·Ongoing·Medtronic Minimed·June 9, 2021

    MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF CDS860016R; 8) LAPAROTOMY CDS #31-RF, REF CDS860062R; 9) LAPAROTOMY CDS #31-RF, REF CDS860062S; 10) LAPAROSCOPY CDS, REF CDS860194I; 11) BASIC LAPAROSCOPY CDS, REF CDS920080R; 12) BASIC LAPAROSCOPY CDS, REF CDS920080S; 13) BASIC LAPAROSCOPY CDS, REF CDS920080T; 14) GENERAL LAPAROSCOPY, REF CDS930027U; 15) GENERAL LAPAROSCOPY, REF CDS930027V; 16) MINOR BASIC-LF, REF CDS930120G; 17) MINOR BASIC-LF, REF CDS930120I; 18) MAJOR DRAPE-LF, REF CDS930121L; 19) GENERAL LAPAROSCOPY PROCEDURE, REF CDS930125U; 20) GENERAL MINOR CDS, REF CDS980246V; 21) MAJOR PROCEDURE-LF, REF CDS980255T; 22) MAJOR LAPAROTOMY, REF CDS981133K; 23) MAJOR LAPAROTOMY KIT, REF CDS981316T; 24) MINOR KIT, REF CDS981317V; 25) BAPTIST NORTH MAJOR CDS, REF CDS982410L; 26) MINOR PROCEDURE CDS-LF, REF CDS982923N; 27) GEN SURG LAPAROSCOPY CDS-LF, REF CDS982926L; 28) LAPAROTOMY CDS, REF CDS983412I; 29) GENERAL LAPAROSCOPY CDS, REF CDS983418I; 30) MINOR-LF, REF CDS983862D; 31) MAJOR ABDOMINAL CDS, REF CDS983908P; 32) LAP CHOLE CDS, REF CDS983912W; 33) LAP CHOLE CDS, REF CDS983912X; 34) GENERAL SURGERY CDS, REF CDS983914L; 35) NHP GENERAL LAPAROSCOPY CDS, REF CDS984232I; 36) GENERAL LAP, REF CDS984251N; 37) ROBOTIC, REF CDS984262M; 38) MINOR CDS, REF CDS984274K; 39) MINOR CDS, REF CDS984274L; 40) MAJOR CDS, REF CDS984277L; 41) MAJOR CDS, REF CDS984277M; 42) SMH MAJOR CDS, REF CDS984588L; 43) MAJOR CDS-LF, REF CDS984599G; 44) MINOR CDS-LF, REF CDS984600G; 45) MINOR PROCEDURE, REF CDS984897K; 46) MINOR PROCEDURE, REF CDS984897L; 47) GENERAL LAPAROSCOPY CDS, REF CDS984901K; 48) GENERAL LAPAROSCOPY CDS, REF CDS984901L; 49) GENERAL LAPAROSCOPY CDS, REF CDS984901M; 50) DAY SURG MAJOR CDS, REF CDS984994M; 51) DAY SURG MAJOR CDS, REF CDS984994N; 52) MINOR SURGERY CDS, REF CDS985321K; 53) LAPAROTOMY CDS-LF, REF CDS985327I; 54) GENERAL LAPAROSCOPY CDS, REF CDS985328J; 55) LAP MAJOR, REF CDS985348F; 56) GENERAL LAPAROSCOPY CDS, REF CDS985422J; 57) GENERAL LAPAROSCOPY CDS, REF CDS985422K; 58) LAPAROTOMY CDS, REF CDS985426I; 59) LAPAROTOMY CDS, REF CDS985426J; 60) LAPAROTOMY CDS, REF CDS985426K; 61) ACH MINOR PROCEDURE, REF CDS985451G; 62) ACH MAJOR ABDOMINAL, REF CDS985454I; 63) SCOPE LAP THOR PACK, REF DYNJ00210L; 64) SCOPE LAP THOR PACK, REF DYNJ00210M; 65) MAJOR LAPAROTOMY PACK, REF DYNJ00387O; 66) GER LAPTMPK RFID-LF, REF DYNJ0100957K; 67) LAKELAND HERNIA PACK RFID-LF, REF DYNJ0101477K; 68) SJ EXPLORATORY LAP PACK-LF, REF DYNJ0101482I; 69) SJ EXPLRTRY LP PK RFID-LF, REF DYNJ0101482J; 70) MINOR PACK-LF, REF DYNJ0105608G; 71) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 72) CYSTO PACK, REF DYNJ01920N; 73) LAP CHOLE PACK, REF DYNJ02458P; 74) OPEN HERNIA APPY PACK, REF DYNJ02575F; 75) GENERAL ABDOMINAL PACK-LF, REF DYNJ0271195S; 76) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 77) LAPAROTOMY PACK-LF, REF DYNJ0366425N; 78) MAJOR PACK-LF, REF DYNJ0386381L; 79) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 80) LAPAROSCOPY GYN PACK, REF DYNJ05175M; 81) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 82) MINOR PACK-LF, REF DYNJ0531958S; 83) MAJOR PACK-LF, REF DYNJ0531964X; 84) LAP CHOLE PACK-LF, REF DYNJ0537278AD; 85) LAP/CHOLE PACK-LF, REF DYNJ0589896R; 86) LAP/CHOLE PACK-LF, REF DYNJ0589896S; 87) LAP/CHOLE PACK-LF, REF DYNJ0589896T; 88) LAP/CHOLE PACK-LF, REF DYNJ0589896U; 89) LAP/CHOLE PACK-LF, REF DYNJ0589896V; 90) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913K; 91) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913M; 92) LKLND LP CHL PK RFID-LF, REF DYNJ0619913N; 93) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401Q; 94) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401R; 95) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 96) MAJOR LAPAROTOMY PACK-LF, REF DYNJ0751444S; 97) MAJO

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 11, 2024

    Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ0259872M ; 4) EYE BASIN PACK-LF , Pack Number DYNJ0259872MH; 5) BASIN DBL PACK-LF , Pack Number DYNJ0287720N ; 6) PRMC BASIN SET UP PACK-LF , Pack Number DYNJ0321828Q ; 7) PRMC BASIN SET UP PACK-LF , Pack Number DYNJ0321828R ; 8) STANDARD BASIN PACK-LF, Pack Number DYNJ0420605J ; 9) MINOR BASIN PACK-LF , Pack Number DYNJ0515988L ; 10) MINOR BASIN PACK-LF , Pack Number DYNJ0515988M ; 11) MAJOR BASIN PACK-LF , Pack Number DYNJ0515994Q ; 12) MAJOR BASIN SET-LF, Pack Number DYNJ0551335Q ; 13) MINOR BASIN PACK-LF , Pack Number DYNJ0551725M ; 14) MINOR BASIN PACK, Pack Number DYNJ0557071D ; 15) UROLOGY BASIN PACK-LF , Pack Number DYNJ0561216G ; 16) LAKELAND SINGLE BASIN PACK-LF , Pack Number DYNJ0619907I ; 17) LAKELAND SINGLE BASIN PACK-LF , Pack Number DYNJ0619907K ; 18) LKLND SNGL BASIN PK RFID-LF , Pack Number DYNJ0619907L ; 19) OPEN HEART C--BASIN PACK-LF, Pack Number DYNJ0867331G; 20) OPEN HEART C--BASIN PACK-LF, Pack Number DYNJ0867331I; 21) TOTAL KNEE BASIN B PACK-LF, Pack Number DYNJ0867555L ; 22) VAG DELIVERY BASIN-LF , Pack Number DYNJ16162I ; 23) MAJOR BASIN PACK, Pack Number DYNJ16629F ; 24) GENERAL BASIN PACK, Pack Number DYNJ16731J ; 25) ST. ANNE'S MINOR BASIN PACK , Pack Number DYNJ24622K ; 26) ST. ANNE'S MAJOR BASIN SET UP , Pack Number DYNJ24628M ; 27) B.A.P BASIN PACK, Pack Number DYNJ28855C ; 28) MAJOR PK W/BASIN MARYVIEW-LF, Pack Number DYNJ30506L ; 29) GYN LAPAROSCOPIC, Pack Number DYNJ31939D ; 30) MAJOR BASIN KIT , Pack Number DYNJ33438G ; 31) BASIN SET , Pack Number DYNJ33967D ; 32) MINOR BASIN PACK-LF , Pack Number DYNJ34575D ; 33) MINOR GEN BASIN PK 9128188-LF , Pack Number DYNJ35972L ; 34) BASIN PACK-LF , Pack Number DYNJ36419D ; 35) MINOR SINGLE BASIN PACK , Pack Number DYNJ37698K ; 36) MINOR SINGLE BASIN PACK , Pack Number DYNJ37698L ; 37) CVG BASIN PACK SC , Pack Number DYNJ38052G ; 38) NEURO BASIN PACK-LF , Pack Number DYNJ39461J ; 39) HEART BASIN TRAY, Pack Number DYNJ44396I ; 40) BASIN PACK, Pack Number DYNJ44706F ; 41) ARTHROSCOPY BASIN SET-LF, Pack Number DYNJ47944D ; 42) ARTHROSCOPY BASIN SET-LF, Pack Number DYNJ47944F ; 43) ORTHOPEDIC CUSTOM BASIN SET , Pack Number DYNJ47991J ; 44) ORTHOPEDIC CUSTOM BASIN SET , Pack Number DYNJ47991N ; 45) RMC BASIN PACK, Pack Number DYNJ48643K ; 46) RMC BASIN PACK, Pack Number DYNJ48643L ; 47) OPEN HEART BASIN PACK-6214, Pack Number DYNJ49530B ; 48) ROBOTIC BASIN PACK, Pack Number DYNJ49536B ; 49) MINOR BASIN PACK, Pack Number DYNJ50463D ; 50) MAJOR BASIN PACK, Pack Number DYNJ50464D ; 51) CSC-N TOWEL SET UP PACK , Pack Number DYNJ50876A ; 52) BASIN SET , Pack Number DYNJ50906F ; 53) PK-SET UP-LF, Pack Number DYNJ51808B ; 54) DOUBLE BASIN OR SET , Pack Number DYNJ51940C ; 55) TR-MINOR KIT-LF , Pack Number DYNJ54801D ; 56) TR-MINOR KIT-LF , Pack Number DYNJ54801F ; 57) TR-MINOR KIT-LF, Pack Number DYNJ54801F ; 58) MAJOR PACK, Pack Number DYNJ55895C ; 59) ORTHO PACK, Pack Number DYNJ55896C ; 60) LITHOTOMY PACK, Pack Number DYNJ55900C ; 61) LAMINECTOMY-DISCECTOMY PACK , Pack Number DYNJ57263B ; 62) BASIN PACK, Pack Number DYNJ57465D ; 63) MAJOR BASIN PACK, Pack Number DYNJ57928C ; 64) PK-MAD,SPINE, Pack Number DYNJ58060I ; 65) SINGLE BASIN PACK-LF, Pack Number DYNJ58389D ; 66) SINGLE BASIN PACK-LF, Pack Number DYNJ58389F ; 67) MINOR SINGLE BASIN-LF , Pack Number DYNJ59649A ; 68) MAJOR BASIN PACK, Pack Number DYNJ59816A ; 69) FLAP PACK , Pack Number DYNJ60224C ; 70) FLAP PACK, Pack Number DYNJ60224D; 71) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529A ; 72) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529B ; 73) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529C ; 74) SINGLE BASIN PACK ST VINCENT, Pack Number DYNJ60529D ; 75) AV FISTULA, Pack Number DYNJ60614C ; 76) BASIN PACK, Pack Number

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024