BEUDAMED
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    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *NOT DISTRIBUTED WITHIN THE US

    FDA Enforcement
    Class II ·Ongoing·INNOVATIVE TOMOGRAPHY PRODUCT GMBH·August 4, 2021

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number CVI4805; e) ED CENTRAL LINE KIT, Model Number CVI4865; f) NO CATH MIDLINE INSERTION KIT, Model Number CVI4950A; g) CENTRAL LINE PROCEDURE KIT, Model Number DT22260; h) ADULT EPIV INSERTION TRAY, Model Number DYNDA2482; i) ULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669; j) I.R. PICC PACK, Model Number DYNDA2759; k) IR SONO PACK, Model Number DYNDA3010; l) NEONATAL PICC LINE TRAY, Model Number DYNDC2120B; m) PICC SUPPLEMENTAL KIT, Model Number DYNDC2373A; n) CENTRAL LINE KIT, Model Number DYNDC2582A; o) CENTRAL LINE KIT UTMB, Model Number DYNDC3061; p) FNA TRAY, Model Number DYNDH1123B; q) CVL PACK, Model Number DYNJ00281O; r) CENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O; s) CENTRAL LINE PACK-LF, Model Number DYNJ0220136Q; t) PICC LINE PACK-LF, Model Number DYNJ0235859I; u) PICC LINE PACK-LF, Model Number DYNJ0235859J; v) PICC LINE PACK-LF, Model Number DYNJ0235859K; w) PICC LINE PACK, Model Number DYNJ04592K; x) PICC LINE PACK-LF, Model Number DYNJ0678523N; y) PICC LINE PACK-LF, Model Number DYNJ0855123N; z) PICC INSERTION PACK-LF, Model Number DYNJ0880659F; aa) PICC PACK-LF, Model Number DYNJ0940720D; bb) VENOUS ACCESS PACK-LF, Model Number DYNJ09895R; cc) PICC PACK-LF, Model Number DYNJ17086A; dd) VENOUS ACCESS TRAY, Model Number DYNJ20094L; ee) PICC LINE PACK-LF, Model Number DYNJ21575I; ff) CENTRAL LINE PACK, Model Number DYNJ30087C; gg) PICC LINE PACK, Model Number DYNJ30233C; hh) PICC PACK, Model Number DYNJ30566B; ii) CENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G; jj) PICC TRAY, Model Number DYNJ33005F; kk) PICC TRAY, Model Number DYNJ33005G; ll) PICC LINE INSERTION TRAY, Model Number DYNJ34241; mm) PICC PACK-LF, Model Number DYNJ35000I; nn) PORT PACK, Model Number DYNJ35163C; oo) PICC TRAY-LF, Model Number DYNJ35272; pp) PICC LINE INSERTION PACK, Model Number DYNJ38868K; qq) PICC LINE INSERTION PACK, Model Number DYNJ38868L; rr) PICC ACCESSORY TRAY, Model Number DYNJ39039M; ss) CVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B; tt) PICC INSERTION PACK MH-LF, Model Number DYNJ40206B; uu) ACCESS PICC PACK, Model Number DYNJ40682B; vv) PHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C; ww) MV-IR-PICC PACK-LF, Model Number DYNJ41554C; xx) PICC TRAY, Model Number DYNJ41648; yy) CENTRAL LINE TRAY, Model Number DYNJ42902C; zz) CENTRAL LINE TRAY, Model Number DYNJ42902D; aaa) VENOUS PACK, Model Number DYNJ43168; bbb) VENOUS PACK, Model Number DYNJ43168A; ccc) VENOUS PACK, Model Number DYNJ43168B; ddd) IR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G; eee) WEST VALLEY PICC LINE PACK, Model Number DYNJ43975A; fff) VENOUS LIGATION PACK, Model Number DYNJ43981G; ggg) VEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C; hhh) VENOUS ABLATION, Model Number DYNJ44904C; iii) PICC LINE PACK, Model Number DYNJ47037C; jjj) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B; kkk) CENTRAL LINE PACK, Model Number DYNJ48096B; lll) PICC PACK-LF, Model Number DYNJ48120B; mmm) AV FISTULA PACK-LF, Model Number DYNJ48428C; nnn) VIEN CLOSURE, Model Number DYNJ49180A; ooo) ARTERIAL LINE PACK, Model Number DYNJ49235D; ppp) PICC PACK, Model Number DYNJ52255; qqq) PICC LINE TRAY, Model Number DYNJ52688B; rrr) PICC LINE TRAY, Model Number DYNJ52688C; sss) CENTRAL LINE INSERTION KIT, Model Number DYNJ52894A; ttt) ARTERIOGRAM PACK, Model Number DYNJ53095A; uuu) ENDOVENOUS ABLATION PACK, Model Number DYNJ53435D; vvv) MID HUDSON PICC LINE PACK, Model Number DYNJ53618A; www) MSB BEDSIDE TRAY, Model Number DYNJ54670; xxx) LEE VEIN PACK, Model Number DYNJ54906C; yyy) ARTERIOGRAM PACK, Model Number DYNJ55169G; zzz) PICC LINE PACK, Model Number DYNJ55170B; aaaa) PICC LINE PACK, M

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures

    FDA Enforcement
    Class II ·Terminated·Bien Air Dental SA·September 30, 2015

    Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

    FDA Enforcement
    Class II ·Ongoing·Bien-Air Surgery Sa·October 28, 2020

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292

    FDA Enforcement
    Class II ·Ongoing·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.·January 31, 2024

    Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ59632F; 42) CATH LAB PACK WITH NAMIC, Model Number: DYNJ60853D; 43) ANGIO PACK ALEX, Model Number: DYNJ63539C; 44) ANGIOGRAPHY CV RAD PACK, Model Number: DYNJ64936B; 45) CATH LAB PACK, Model Number: DYNJ65185D; 46) CATH PACK, Model Number: DYNJ65619A; 47) CATH I W SPLIT DRAPE PACK, Model Number: DYNJ66182; 48) CATH PACK SHD, Model Number: DYNJ68384B; 49) CATH LAB PACK, Model Number: DYNJ69094B; 50) CATH LAB ACCESSORIES, Model Number: DYNJ69213B; 51) REYES CATH PACK, Model Number: DYNJ69345A; 52) TMH ANGIOGRAPHY TRAY, Model Number: DYNJ80054A; 53) ANGIOGRAPHY TRAY, Model Number: DYNJ80156; 54) CATH PACK, Model Number: DYNJ80516C; 55) CATH PACK, Model Number: DYNJ80730; 56) ANGIO DRAPE PACK 2 WINDOW, Model Number: DYNJ81066B; 57) OR ANGIOGRAM PACK, Model Number: DYNJ81435F; 58) HEART CATH PACK, Model Number: DYNJ81527B; 59) HEART CATH PACK, Model Number: DYNJ83764D; 60) CATH LAB PACK, Model Number: DYNJ84048A; 61) ANGIO TRAY NO LIDO, Model Number: DYNJ85557B; 62) CARDIAC CATH PACK, Model Number: DYNJ85746B; 63) ANGIOGRAPHY PACK, Model Number: DYNJ86313; 64) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ86787; 65) CATH PACK, Model Number: DYNJ87098A; 66) CATH LAB TAVR PACK, Model Number: DYNJ88532; 67) SMT LEFT HEART CATH, Model Number: DYNJ89274; 68) VASCULAR CATH PACK, Model Number: DYNJ89352; 69) CATH LAB PACK, Model Number: DYNJ89805; 70) CARDIAC CATH MERCY WASHINGTON, Model Number: DYNJ89934; 71) ANGIO, Model Number: DYNJ900278G; 72) TAVR ICC VER. F, Model Number: DYNJ904401F; 73) TAVR, Model Number: DYNJ908646C; 74) LHK-UPMC CHILDRENS MAIN OR 2, Model Number: NAM0009; 75) KIT ANGIO CSTM-EVERGREEN, Model Number: NAM0020; 76) GP-CARDIAC CATH PACK-LF, Model Number: PHS397170009D; 77) LEFT HEART KIT - MARION, Model Number: VASC1073A; 78) RHK - VAMC RICHMOND, Model Number: VASC1185B; 79) LHK-MEADOWVIEW REG, Model Number: VASC1263; 80) LHK - BSC 3V ON S10RA, Model Number: VASC1269; 81) LHK - BSC 3V ON S10MLL, Model Number: VASC1270; 82

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·April 29, 2026

    Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS780056L ; 6) SHUNT CDS-LF, Pack Number CDS780103K ; 7) NEURO CDS , Pack Number CDS780108T ; 8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ; 9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ; 10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ; 11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ; 12) NEURO CDS , Pack Number CDS780162AA; 13) NEURO CDS , Pack Number CDS780162AB; 14) NEURO CDS , Pack Number CDS780162AC; 15) NEURO CDS , Pack Number CDS780162AD; 16) NEURO CDS , Pack Number CDS780162X ; 17) NEURO CDS , Pack Number CDS780162Y ; 18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ; 19) BASIC NEURO PACK, Pack Number CDS780202L ; 20) BASIC NEURO PACK, Pack Number CDS780202O ; 21) BASIC NEURO PACK, Pack Number CDS780202P ; 22) BASIC NEURO PACK, Pack Number CDS780202Q ; 23) BASIC NEURO PACK, Pack Number CDS780202R ; 24) NEURO-LAMI CDS, Pack Number CDS780208D ; 25) NEURO-LAMI CDS, Pack Number CDS780208F ; 26) NEURO CDS, Pack Number CDS780230K; 27) NEURO CDS , Pack Number CDS780230K ; 28) VP SHUNT, Pack Number CDS840193U ; 29) NEURO CDS-LF, Pack Number CDS980853N ; 30) VP SHUNT CDS-LF , Pack Number CDS981084K ; 31) VP SHUNT CDS-LF , Pack Number CDS981084L ; 32) VP SHUNT CDS-LF , Pack Number CDS981084M ; 33) NEURO KIT , Pack Number CDS981327N ; 34) NEURO KIT , Pack Number CDS981327O ; 35) NEURO KIT , Pack Number CDS981327P ; 36) NERVE STIMULATOR, Pack Number CDS981579N ; 37) NEURO MINOR CDS , Pack Number CDS981708K ; 38) VP SHUNT CDS, Pack Number CDS981740F ; 39) VP SHUNT CDS, Pack Number CDS981740J ; 40) VP SHUNT CDS, Pack Number CDS981740K ; 41) VP SHUNT CDS, Pack Number CDS981740KH; 42) MICRO DISC CDS, Pack Number CDS981886P ; 43) MICRO DISC CDS, Pack Number CDS981886R ; 44) MICRO DISC CDS, Pack Number CDS981886S ; 45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ; 46) NEURO CDS , Pack Number CDS982603L ; 47) NEURO CDS , Pack Number CDS982603M ; 48) NEURO CDS , Pack Number CDS982603N ; 49) NEURO SPINE CDS , Pack Number CDS982683Q ; 50) MAJOR NEURO , Pack Number CDS982704K ; 51) MAJOR NEURO , Pack Number CDS982704M ; 52) MAJOR NEURO , Pack Number CDS982704N ; 53) NEURO CDS CHS-LF, Pack Number CDS982745D ; 54) NEURO CDS CHS-LF, Pack Number CDS982745F ; 55) NEURO CDS CHS-LF, Pack Number CDS982745G ; 56) AV SHUNT CDS, Pack Number CDS983098D ; 57) AV SHUNT CDS, Pack Number CDS983098F ; 58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ; 59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ; 60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ; 61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ; 62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ; 63) VP SHUNT, Pack Number CDS983366J ; 64) VP SHUNT, Pack Number CDS983366M ; 65) VP SHUNT, Pack Number CDS983366N ; 66) VP SHUNT, Pack Number CDS983366P ; 67) NEURO CDS-LF, Pack Number CDS983383F ; 68) NEURO CDS-LF, Pack Number CDS983383G ; 69) NEURO CDS-LF, Pack Number CDS983383I ; 70) NEURO CDS-LF, Pack Number CDS983383J ; 71) AV SHUNT CDS, Pack Number CDS983792C ; 72) AV SHUNT CDS, Pack Number CDS983792D ; 73) ANTERIOR NEURO CDS, Pack Number CDS983882C ; 74) ANTERIOR NEURO CDS, Pack Number CDS983882D ; 75) POSTERIOR NEURO CDS , Pack Number CDS983885C ; 76) POSTERIOR NEURO CDS , Pack Number CDS983885D ; 77) POSTERIOR NEURO CDS , Pack Number CDS983885F ; 78) NEURO CDS , Pack Number CDS983981D ; 79) NEURO CDS , Pack Number CDS983981F ; 80) NEURO CDS , Pack Number CDS983981I ; 81) NEURO CDS , Pack Number CDS983981J ; 82) NEURO CDS , Pack Number CDS983981K ; 83) NEURO CDS , Pack Number CDS983981L ; 84) CRANI NEURO CDS , Pack Number CDS984172F ; 85) PUH NEURO EEA CDS , Pack Number CDS984297G ; 86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ; 87) ME

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