BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy

    FDA Enforcement
    Class I ·Ongoing·Percussionaire Corporation·November 6, 2024

    Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·January 14, 2026

    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H

    FDA Enforcement
    Class II ·Ongoing·Ethicon, Inc.·June 26, 2024

    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 26, 2025

    Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

    Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 4, 2026

    Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702

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

    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF, Pack Number DYNJ55345D; 7) C-SECTION PACK, Pack Number DYNJ04521J; 8) C-SECTION PACK, Pack Number DYNJ32632F; 9) C-SECTION PACK, Pack Number DYNJ65961B; 10) SMJ C-SECTION PACK-LF, Pack Number DYNJ38582J

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

    MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION PROCEDURE, REF CDS983450L; 8) C-SECTION-LF, REF CDS983869J; 9) C-SECTION, REF CDS984261J; 10) C-SECTION CDS-LF, REF CDS984516L; 11) C-SECTION CDS-LF, REF CDS984516M; 12) C-SECTION, REF CDS984902K; 13) C-SECTION, REF CDS984902L; 14) C-SECTION CDS, REF CDS985282F; 15) C-SECTION CDS, REF CDS985326G; 16) C SECTION, REF CDS985505G; 17) C-SECTION, REF CDSCCR611Q; 18) C-SEC GERBERUNI PK RFID-LF, REF DYNJ0100978K; 19) C-SECTION PACK-LF, REF DYNJ0101147G; 20) BR C-SECTION-LF, REF DYNJ0101562I; 21) BR C-SEC RFID-LF, REF DYNJ0101562K; 22) LUD C-SEC RFID-LF, REF DYNJ0101616L; 23) C-SECTION PACK-LF, REF DYNJ0173422AF; 24) C-SECTION PACK-LF, REF DYNJ0173422AG; 25) C-SECTION PACK-LF, REF DYNJ0190625Q; 26) C-SECTION PACK, REF DYNJ02577D; 27) SUT C-SECTION PACK, REF DYNJ02748F; 28) C-SECTION PACK-LF, REF DYNJ0282506N; 29) C-BIRTH PACK-LF, REF DYNJ0366291O; 30) C SECTION PACK-LF, REF DYNJ0378325M; 31) C SECTION PACK-LF, REF DYNJ0378325N; 32) C SECTION PACK-LF, REF DYNJ0451410O; 33) C-SECTION PACK-LF, REF DYNJ0536924T; 34) C-SECTION PACK-LF, REF DYNJ0536924U; 35) C-SECTION PACK-LF, REF DYNJ0551169V; 36) C-SECTION PACK-LF, REF DYNJ0551409O; 37) LAKELAND C-SECTION PACK-LF, REF DYNJ0619806K; 38) LKLND C-SEC PK RFID-LF, REF DYNJ0619806O; 39) C-SECTION PACK-LF, REF DYNJ0778455D; 40) C-SECTION PACK-LF, REF DYNJ0778455F; 41) C-SECTION PACK-LF, REF DYNJ0778455G; 42) C-SECTION PACK-LF, REF DYNJ07836Q; 43) C-SECTION PACK-LF, REF DYNJ0842739L; 44) C-SECTION PACK-LF, REF DYNJ0842739M; 45) C SECTION PACK-LF, REF DYNJ0854363I; 46) C SECTION PACK-LF, REF DYNJ0854363J; 47) C-SECTION PACK-LF, REF DYNJ0868053S; 48) C-SECTION TRAY-LF, REF DYNJ09174O; 49) C-SECTION TRAY, REF DYNJ16026G; 50) C-SECTION TRAY, REF DYNJ16026I; 51) C-SECTION PACK, REF DYNJ16614B; 52) C-SECTION PACK, REF DYNJ19417P; 53) C-SECTION PACK, REF DYNJ19417Q; 54) C-SECTION PACK, REF DYNJ19417R; 55) C-SECTION PACK-LF, REF DYNJ21569I; 56) C-SECTION PACK, REF DYNJ23432I; 57) C-SECTION LF-OR, REF DYNJ24232I; 58) C-SECTION LF-OR, REF DYNJ24232J; 59) SVMMC C-SECTION PACK, REF DYNJ24632K; 60) ST. CHARLES C-SECTION PACK, REF DYNJ24710I; 61) C-SECTION PACK, REF DYNJ25939N; 62) C-SECTION PACK, REF DYNJ26693M; 63) C-SECTION PACK, REF DYNJ30064O; 64) C-SECTION PACK, REF DYNJ30064P; 65) C-SECTION PACK, REF DYNJ32229M; 66) C-SECTION PACK, REF DYNJ32229N; 67) C-SECTION PACK, REF DYNJ32229O; 68) CUH C-SECTION PACK-LF, REF DYNJ32253G; 69) C-SECTION PACK, REF DYNJ32632F; 70) C-SECTION PACK-LF, REF DYNJ33059B; 71) C SECTION, REF DYNJ37535C; 72) C-SECTION PACK-LF, REF DYNJ37606J; 73) C-SECTION PACK SC-LF, REF DYNJ38063D; 74) C-SECTION PACK, REF DYNJ38229C; 75) C-SECTION PACK SC-LF, REF DYNJ38700G; 76) C-SECTION PACK-LF, REF DYNJ38845D; 77) C SECTION PACK, REF DYNJ43024D; 78) C SECTION PACK, REF DYNJ43024G; 79) C-SECTION PACK-CC, REF DYNJ43146F; 80) C-SECTION PACK, REF DYNJ44679L; 81) C-SECTION PACK, REF DYNJ44773S; 82) C-SECTION PACK, REF DYNJ44773T; 83) C-SECTION PACK, REF DYNJ44773U; 84) NMH C-SECTION PACK, REF DYNJ44773V; 85) C-SECTION PACK, REF DYNJ44861K; 86) C-SECTION TRAY, REF DYNJ46470F; 87) C-SECTION DELIVERY PACK-LF, REF DYNJ47808D; 88) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 89) C SECTION PACK, REF DYNJ48087F; 90) WMC C-SECTION PACK-LF, REF DYNJ50655I; 91) C-SECTION I, REF DYNJ51354B; 92) C SECTION PACK, REF DYNJ51872D; 93) C SECTION PACK-LF, REF DYNJ52387M; 94) C SECT PK RFID-LF, REF DYNJ52387N; 95) C-SECTION PACK, REF DYNJ53528C; 96) C SECTION, REF DYNJ53654F; 97) C SECTION, REF DYNJ53654G; 98) C SECTION PACK, REF DYNJ54148D; 99) C SECTION PACK-LF, REF DYNJ54374J; 100) CMH C SECTION PACK-LF, REF DYNJ54374L; 101) MAG C-SECTION PREP

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

    Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack Number CDS820081L ; 7) C-SECTION CDS , Pack Number CDS820103J ; 8) C-SECTION CDS , Pack Number CDS820103K ; 9) UVALDE C-SECTION CDS, Pack Number CDS820116F ; 10) UVALDE C-SECTION CDS, Pack Number CDS820116G ; 11) C-SECTION CDS , Pack Number CDS820136O ; 12) C-SECTION CDS , Pack Number CDS820136P ; 13) C-SECTION CDS , Pack Number CDS820136Q ; 14) C-SECTION CDS , Pack Number CDS820136R ; 15) C-SECTION CDS , Pack Number CDS820136S ; 16) C-SECTION CDS , Pack Number CDS820136T ; 17) C-SECTION CDS , Pack Number CDS820136U ; 18) C-SECTION CDS , Pack Number CDS820152F ; 19) C-SECTION CDS , Pack Number CDS820152G ; 20) C-SECTION CDS , Pack Number CDS820152I ; 21) C-SECTION CDS , Pack Number CDS980774J ; 22) C-SECTION , Pack Number CDS980774K ; 23) C-SECTION , Pack Number CDS980774L ; 24) C-SECTION , Pack Number CDS980774M ; 25) C-SECTION CDS WOR-LF, Pack Number CDS981707F ; 26) C-SECTION CDS , Pack Number CDS981777L ; 27) C-SECTION CDS , Pack Number CDS981777M ; 28) C-SECTION CDS , Pack Number CDS981777N ; 29) C-SECTION CDS-LF, Pack Number CDS982258F ; 30) C-SECTION CDS-LF, Pack Number CDS982258G ; 31) C-SECTION CDS-LF, Pack Number CDS982258I ; 32) C-SECTION CDS , Pack Number CDS982267F ; 33) C-SECTION CDS , Pack Number CDS982267G ; 34) C-SECTION CDS , Pack Number CDS982267I ; 35) C-SECTION CDS , Pack Number CDS982267J ; 36) C-SECTION CDS , Pack Number CDS982328J ; 37) C-SECTION CDS , Pack Number CDS982328K ; 38) C-SECTION CDS , Pack Number CDS982328L ; 39) C-SECTION CDS , Pack Number CDS982328M ; 40) C-SECTION CDS , Pack Number CDS982328O ; 41) C-SECTION CDS , Pack Number CDS982328P ; 42) C-SECTION CDS , Pack Number CDS982367G ; 43) C-SECTION COMBINED CDS, Pack Number CDS982398G ; 44) C-SECTION COMBINED CDS, Pack Number CDS982398I ; 45) C-SECTION CDS , Pack Number CDS982416O ; 46) C SECTION CDS CHS , Pack Number CDS982739F ; 47) C SECTION CDS CHS , Pack Number CDS982739J ; 48) C-SECTION CDS , Pack Number CDS983117C ; 49) C-SECTION CDS , Pack Number CDS983117D ; 50) C-SECTION CDS , Pack Number CDS983117F ; 51) C-SECTION CDS , Pack Number CDS983117G ; 52) C-SECTION PROCEDURE , Pack Number CDS983450I ; 53) C-SECTION PROCEDURE , Pack Number CDS983450J ; 54) C-SECTION PROCEDURE , Pack Number CDS983450K ; 55) C-SECTION PROCEDURE , Pack Number CDS983450L ; 56) C-SECTION PROCEDURE , Pack Number CDS983450M ; 57) C-SECTION CDS , Pack Number CDS983523D ; 58) C-SECTION CDS , Pack Number CDS983523F ; 59) C-SECTION CDS , Pack Number CDS983523G ; 60) C-SECTION CDS-LF, Pack Number CDS983869I ; 61) C-SECTION-LF, Pack Number CDS983869J ; 62) C-SECTION CDS , Pack Number CDS983897G ; 63) C-SECTION CDS , Pack Number CDS983897I ; 64) C-SECTION CDS , Pack Number CDS983934I ; 65) C-SECTION CDS , Pack Number CDS983998C ; 66) C-SECTION DELIVERY CDS, Pack Number CDS984018; 67) C-SECTION DELIVERY CDS, Pack Number CDS984018A ; 68) C-SECTION CDS , Pack Number CDS984554B ; 69) C SECTION CDS , Pack Number CDS984616A ; 70) C-SECTION CDS , Pack Number CDS984768D ; 71) C-SECTION CDS , Pack Number CDS984768F ; 72) C-SECTION , Pack Number CDS984902G ; 73) C-SECTION , Pack Number CDS984902I ; 74) C-SECTION , Pack Number CDS984902J ; 75) C-SECTION , Pack Number CDS984902K ; 76) C-SECTION CDS , Pack Number CDS985206B ; 77) C-SECTION CDS , Pack Number CDS985257G ; 78) C-SECTION CDS , Pack Number CDS985257I ; 79) C-SECTION CDS , Pack Number CDS985257J ; 80) C-SECTION CDS , Pack Number CDS985257L ; 81) C SECTION , Pack Number CDS985505G ; 82) C-SECTION , Pack Number CDS985560N ; 83) C-SECTION SET-UP PACK , Pack Number CDSOBL122F ; 84) C-SECTION SET-UP PACK , Pack Number CDSOBL122G ; 85) C-SECTION SET-UP PACK , Pack Number CD

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