17 results
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8ms
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Sources: EU EUDAMED, US FDA
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·July 31, 2024
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 22, 2024
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
FDA Enforcement
Class II
·Ongoing·UIH Technologies LLC·October 29, 2025
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
FDA Enforcement
Class II
·Ongoing·Dentsply IH, Inc.·September 3, 2025
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component
FDA Enforcement
Class II
·Ongoing·Dentsply IH, Inc.·September 3, 2025
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ82989; d. SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267; e. TV IR PICC PACK-LF, Model Number: DYNJ41561D; f. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635A; g. ULTRASOUND GUIDED PIV KIT, Model Number: DYNDA2669; h. USG PIV INSERTION KIT, Model Number: DYNDV2480; i. VASCULAR, Model Number: DYNJ907965; j. VASCULAR ACCESS, Model Number: DYNJ901340A; k. VASCULAR ACCESS TRAY, Model Number: DYNJ52606B; l. VASCULAR ACCESS-LF, Model Number: DYNJ905285D; m. VASCULAR ENDO LASER PK, Model Number: DYNJ37445G; n. VASCULAR PACK, Model Number: DYNJ66356F; o. VASCULAR VEIN PACK, Model Number: DYNJ69769; p. VEIN ABLATION, Model Number: DYNJ63268C, DYNJ63268D, DYNJ66079A; q. VEIN ABLATION KIT, Model Number: DYNJ69272; r. VEIN ABLATION PACK, Model Number: DYNJ62889A, DYNJ62889B, DYNJ69288; s. VEIN ABLATION PLUS W CHL, Model Number: DYNJ67115A; t. VEIN CLOSURE, Model Number: DYNJ49180A; u. VEIN CLOSURE PACK, Model Number: DYNJ69976, DYNJ69976A, DYNJ81834; v. VEIN CLOSURE TRAY - NIVC, Model Number: DYNJ44737C; w. VEIN HARVESTING PACK, Model Number: DYNJ82933; x. VEIN LIGATION, Model Number: DYNJ64190B; y. VEIN OHH, Model Number: DYNJ65560C; z. VEIN PACK, Model Number: DYNJ66743B, DYNJ69091A, DYNJ69091B, DYNJ69177, DYNJ69942, DYNJ69942A, DYNJ81120, DYNJ81212A, DYNJ83914; aa. VEIN PACK-LF, Model Number: DYNJ66271B, DYNJ66271D; bb. VEIN PROCEDURE PACK, Model Number: DYNJ62038B, DYNJ81177; cc. VEIN PROCEDURE TRAY, Model Number: DYNJ82581; dd. VENCLOSE PROCEDURE PACK 7CM, Model Number: VC-PPH-6F7A; ee. VENCLOSE PROCEDURE PACK MAVEN, Model Number: VC-PPM-12F; ff. VENCLOSE PROCEDURE PACK, 12CM, Model Number: VC-PP-6F12, VC-PPH-6F12A; gg. VENOUS ABLATION, Model Number: DYNJ44904B, DYNJ44904C; hh. VENOUS ACCESS, Model Number: DYNJ59751B; ii. VENOUS ACCESS PACK, Model Number: DYNJ44421B; jj. VENOUS ACCESS TRAY, Model Number: DYNJ20094L; kk. VENOUS LIGATION PACK, Model Number: DYNJ43981G; ll. VENOUS PACK, Model Number: DYNJ43168, DYNJ43168A, DYNJ43168B, DYNJ56260A, DYNJ56447B, DYNJ62711A, DYNJ66499A, DYNJ66499B, DYNJ80169, DYNJ80169A, DYNJ80692; mm. VNUS PACK, Model Number: DYNJ59246A; nn. WEST VALLEY PICC LINE PACK, Model Number: DYNJ43975A;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C, DYNJ66356D, DYNJ66577, DYNJ68492A, DYNJ68492B, DYNJ68492C, DYNJ68492D, DYNJ68863, DYNJ68863A, DYNJ68880, DYNJ80599, DYNJ81626, DYNJ82016, DYNJ82104, DYNJ82144, DYNJ82769, DYNJ82769A, DYNJ83146; b. VASCULAR PACK CHRG, Model Number: DYNJ59778A, DYNJ59778B; c. VASCULAR PACK GWV, Model Number: DYNJ59245; DYNJ59245A; d. VASCULAR PACK MH-LF, Model Number: DYNJ39866B, DYNJ39866C; e. VASCULAR PACK SHD, Model Number: DYNJ68404; f. VASCULAR PACK-LF, Model Number: DYNJ0250564O, DYNJ0250564P, DYNJ0373040N, DYNJ0493141G, DYNJ0493141I, DYNJ0493141J, DYNJ0871182AC, DYNJ0901358I, DYNJ0901358J, DYNJ0901358K, DYNJ53475F, DYNJ53684A, PHS400047N, PHS400047O; g. VASCULAR STENT INOVA, Model Number: DYNJ906440A; h. VASCULAR TRAY, Model Number: DYNJ56858; i. VASCULAR/OR ANGIO, Model Number: DYNJ905079F; j. VASCULAR-LF, Model Number: DYNJ900714B, DYNJ900714C; k. VEIN ABLATION EXCISION ASC, Model Number: DYNJ52586B; l. VEIN ABLATION & EXCISION ASC, Model Number: DYNJ52586, DYNJ52586A, DYNJ52586B; m. VEIN ABLATION KIT, Model Number: DYNJ69272A; n. VEIN ABLATION PACK, Model Number: DYNJ62889; o. VEIN ABLATION TRAY W/CHLOR, Model Number: DYNJ64396; p. VEIN AND LASER PACK, Model Number: DYNJ49874; q. VEIN CENTER PACK, Model Number: DYNJ52123; r. VEIN CLINIC, Model Number: DYNJ68667; s. VEIN CLOSURE PACK, Model Number: DYNJ35586G, DYNJ39408F, DYNJ65189B; t. VEIN CLOSURE TRAY, Model Number: DYNJ44737B; u. VEIN KIT, Model Number: DYNJ57047; v. VEIN LIGATION, Model Number: DYNJ64190; w. VEIN OHH, Model Number: DYNJ65560A; x. VEIN PACK, Model Number: DYNJ21949J, DYNJ39005B, DYNJ39889, DYNJ48493, DYNJ48907F, DYNJ50785, DYNJ52098, DYNJ52993A, DYNJ53160, DYNJ53160A, DYNJ54153B, DYNJ55268, DYNJ55462A, DYNJ55514A, DYNJ55849A, DYNJ56624, DYNJ56724A, DYNJ56724B, DYNJ57512, DYNJ57835, DYNJ57917, DYNJ58063, DYNJ58609, DYNJ59151F, DYNJ59662B, DYNJ59662D, DYNJ59677A, DYNJ59681A, DYNJ61540C, DYNJ63823, DYNJ64282, DYNJ64471A, DYNJ65579, DYNJ66154, DYNJ66743A, DYNJ68749, DYNJ69091, DYNJ80199A, DYNJ80199B, DYNJ80868, DYNJ83147; y. VEIN PACK II, Model Number: DYNJ66427; z. VEIN PACK-LF, Model Number: DYNJ66271A, DYNJ66271C; aa. VEIN PROCEDURE, Model Number: DYNJ65342A; bb. VEIN PROCEDURE PACK, Model Number: DYNJ38264D, DYNJ62038A, DYNJ64909; cc. VEIN SPECIALISTS PACK, Model Number: DYNJ53616A; dd. VEIN TRAY, Model Number: DYNJ57003, DYNJ62829A; ee. VENOUS ABLATION, Model Number: DYNJ50227C; ff. VENOUS ACCESS ACCESSORY PACK, Model Number: DYNJ61010A; gg. VENOUS ACCESS PACK, Model Number: DYNJ44421D; hh. VIRC STROKE PACK, Model Number: DYNJ83461; ii. VNUS, Model Number: CDS984292I; jj. VNUS CLOSURE, Model Number: DYNJ66076; kk. VNUS VASCULAR PACK, Model Number: DYNJ66445; ll. WA VASCULAR PACK-LF, Model Number: DYNJ33612G
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827; f) PICC PACK, Model Number DYNJ65838; g) JVL-PACK PICC, Model Number DYNJ66062; h) FISTULAGRAM PACK, Model Number DYNJ66259; i) VEIN PACK-LF, Model Number DYNJ66271B; j) VEIN PACK-LF, Model Number DYNJ66271D; k) VASCULAR PACK, Model Number DYNJ66356F; l) VENOUS PACK, Model Number DYNJ66499A; m) VENOUS PACK, Model Number DYNJ66499B; n) VEIN PACK, Model Number DYNJ66743B; o) AV FISTULA PACK, Model Number DYNJ66916; p) VEIN ABLATION PLUS W CHL, Model Number DYNJ67115A; q) PICC INSERTION TRAY, Model Number DYNJ67415; r) AFCH CVC INSERTION, Model Number DYNJ67534; s) ENS PICC LINE-HEJ-LF, Model Number DYNJ67606; t) VEIN TRAY, Model Number DYNJ69012A; u) PICC PACK, Model Number DYNJ69088; v) PICC PACK, Model Number DYNJ69088A; w) VEIN PACK, Model Number DYNJ69091A; x) VEIN PACK, Model Number DYNJ69091B; y) VEIN PACK, Model Number DYNJ69177; z) VEIN ABLATION KIT, Model Number DYNJ69272; aa) VEIN ABLATION PACK, Model Number DYNJ69288; bb) BASIC VEIN PACK, Model Number DYNJ69426; cc) VASCULAR VEIN PACK, Model Number DYNJ69769; dd) BCH VEIN ABLATION, Model Number DYNJ69796; ee) VEIN PACK, Model Number DYNJ69942A; ff) FISTULA SAVANNAH PACK, Model Number DYNJ69943; gg) VEIN CLOSURE PACK, Model Number DYNJ69976; hh) VEIN CLOSURE PACK, Model Number DYNJ69976A; ii) VENCLOSE PROCEDURE PACK, Model Number DYNJ80123; jj) VENOUS PACK, Model Number DYNJ80169; kk) VENOUS PACK, Model Number DYNJ80169A; ll) CVR ENDOVENOUS PACK, Model Number DYNJ80643; mm) VENOUS PACK, Model Number DYNJ80692; nn) VENOUS PACK, Model Number DYNJ80692A; oo) VEIN PACK, Model Number DYNJ81120; pp) VEIN PROCEDURE PACK, Model Number DYNJ81177; qq) VEIN PACK, Model Number DYNJ81212A; rr) SUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267; ss) OR VASCULAR ANGIO PACK, Model Number DYNJ81592; tt) PARAGON VEIN PACK, Model Number DYNJ81669; uu) PARAGON VEIN PACK, Model Number DYNJ81669B; vv) ANGIOGRAM-DECH-LF, Model Number DYNJ81725; ww) PICC-DECH-LF, Model Number DYNJ81726; xx) VEIN CLOSURE PACK, Model Number DYNJ81834; yy) VEIN PACK, Model Number DYNJ82033; zz) VEIN PACK, Model Number DYNJ82033A; aaa) SUPERFICIAL VENOUS PACK, Model Number DYNJ82100; bbb) SUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101; ccc) VEIN PROCEDURE TRAY, Model Number DYNJ82581; ddd) VARICOSE VEIN PACK, Model Number DYNJ82884; eee) VARICOSE VEIN PACK, Model Number DYNJ82885; fff) LASER VEIN EC PACK, Model Number DYNJ82951; ggg) SUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989; hhh) PORT DIALYSIS PACK, Model Number DYNJ83087; iii) DEXMED ACCESS PACK, Model Number DYNJ83148; jjj) VEIN TRAY, Model Number DYNJ83384A; kkk) RADIO VEIN ABLATION PACK, Model Number DYNJ83534; lll) VEIN PACK, Model Number DYNJ83747; mmm) VEIN ABLATION PACK, Model Number DYNJ83846; nnn) VEIN PACK, Model Number DYNJ83914; ooo) VEIN PACK, Model Number DYNJ83935; ppp) VEIN ABLATION PACK, Model Number DYNJ83974; qqq) VENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I; rrr) VASCULAR ACCESS-LF, Model Number DYNJ905285D; sss) GENERAL AV FISTULA, Model Number DYNJ906011B; ttt) KIT VEIN ABLATION, Model Number DYNJ907381; uuu) OPEN VASCULAR UE, Model Number DYNJ907858; vvv) PICC LINE TRAY-LF, Model Number DYNJT2272J; www) PICC LINE TRAY-LF, Model Number DYNJT2272K; xxx) PICC CUSTOM PACK, Model Number GSS584Q; yyy) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A; zzz) PEDS/ NICU LINE KIT, Model Number MNS13555; aaaa) ER CENTRAL LINE KIT, Model Number P155508D; bbbb) PICC INSERTION TRAY, Model Number PICC0018; cccc) PICC TRAY, Model Number PICCNC0008; dddd) PQ PICC LINE PACK, Model Number PICCNC0013; eeee) STANDARD PICC II-LF, Model Number
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DYNJ54153B; e) RFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A; f) PEDI EP PACK, Model Number DYNJ54750G; g) EL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C; h) LEE VEIN PACK, Model Number DYNJ54906B; i) HEART FAILURE PK, Model Number DYNJ55528A; j) HEART FAILURE PK, Model Number DYNJ55528B; k) HEART FAILURE PK, Model Number DYNJ55528C; l) ROCKWAY VASCULAR PACK-LF, Model Number DYNJ55757C; m) OPEN HEART ANGIO PACK, Model Number DYNJ55836B; n) DR NACKMAN VEIN PACK, Model Number DYNJ56235; o) KT TAVR PACK, Model Number DYNJ56283D; p) KT TAVR PACK, Model Number DYNJ56283F; q) VEIN PACK, Model Number DYNJ56724B; r) VASCULAR PACK, Model Number DYNJ56791A; s) VASCULAR PACK, Model Number DYNJ56791B; t) ECMO PACK, Model Number DYNJ56904; u) VEIN KIT, Model Number DYNJ57047; v) EH TAVR PACK, Model Number DYNJ57449F; w) EH TAVR PACK, Model Number DYNJ57449G; x) VASCULAR PACK, Model Number DYNJ57490A; y) VEIN PACK, Model Number DYNJ57512; z) DEVICE PACK, Model Number DYNJ57595A; aa) CAROTID PACK-LF, Model Number DYNJ57646B; bb) CAROTID PACK-LF, Model Number DYNJ57646C; cc) CATH LAB PACK, Model Number DYNJ57735F; dd) VEIN PACK, Model Number DYNJ57835; ee) VEIN PACK, Model Number DYNJ57917; ff) ENS. THROMBOLYSE/EMBOLISAT-LF, Model Number DYNJ58179C; gg) HEART VALVE PACK, Model Number DYNJ58365J; hh) VEIN PACK, Model Number DYNJ58609; ii) VASCULAR PACK, Model Number DYNJ58681A; jj) VASCULAR PACK, Model Number DYNJ58681B; kk) VASCULAR PACK, Model Number DYNJ58710; ll) DR HARRISON VEIN PACK II, Model Number DYNJ59028A; mm) VEIN PACK, Model Number DYNJ59151F; nn) EP LAB, Model Number DYNJ59392D; oo) EP LAB, Model Number DYNJ59392F; pp) VEIN PACK, Model Number DYNJ59662D; qq) VEIN PACK, Model Number DYNJ59681A; rr) VASCULAR PACK CHRG, Model Number DYNJ59778B; ss) VASCULAR ACCESS KIT, Model Number DYNJ59796C; tt) CATH PACK, Model Number DYNJ59830A; uu) VENOUS ACCESS ACCESSORY PACK, Model Number DYNJ61010A; vv) DR SIRAGUSA VEIN PACK, Model Number DYNJ61247; ww) MAIN OR CATH LAB, Model Number DYNJ61373; xx) VASCULAR PACK, Model Number DYNJ61528; yy) VASCULAR PACK, Model Number DYNJ61528A; zz) VEIN PACK, Model Number DYNJ61540C; aaa) NEURO VASCULAR PACK, Model Number DYNJ61584A; bbb) ABLATION PACK, Model Number DYNJ61957A; ccc) HEART GROIN PACK, Model Number DYNJ61981C; ddd) PERMA CATH PACK, Model Number DYNJ62007B; eee) PURPLE PACK, Model Number DYNJ62197A; fff) PURPLE PACK, Model Number DYNJ62197B; ggg) CLOVIS CATH LAB PACK, Model Number DYNJ62379A; hhh) VASCULAR PACK, Model Number DYNJ62399A; iii) NORTH TEXAS VASCULAR, Model Number DYNJ62735; jjj) VEIN TRAY, Model Number DYNJ62829A; kkk) HEART VEIN NYC LASER ABLATION, Model Number DYNJ62850A; lll) HEART VEIN NYC -ARTERIAL PACK, Model Number DYNJ62851B; mmm) TAVR PACK, Model Number DYNJ62915B; nnn) PACER SET UP PACK, Model Number DYNJ63069A; ooo) OPEN HEART TAVR PACK, Model Number DYNJ63099D; ppp) OPEN HEART TAVR PACK, Model Number DYNJ63099F; qqq) ELECTROPHYSIOLOGY PACK, Model Number DYNJ63209; rrr) TAVR PACK, Model Number DYNJ63340A; sss) VEIN PACK, Model Number DYNJ63823; ttt) NIR PACK, Model Number DYNJ63892A; uuu) VEIN ABLATION TRAY W/CHLOR, Model Number DYNJ64396; vvv) TORRES-VEIN PACK, Model Number DYNJ64449; www) VEIN PACK, Model Number DYNJ64471A; xxx) CVOR ENDOVASCULAR PACK, Model Number DYNJ64506A; yyy) HEART FAILURE PACK, Model Number DYNJ64877B; zzz) CT ABLATION PACK, Model Number DYNJ64928; aaaa) VEIN PROCEDURE, Model Number DYNJ65342A; bbbb) SMALL TRAY VASCULAR PACK, Model Number DYNJ65418; cccc) VEIN OHH, Model Number DYNJ65560A; dddd) PORT PICC TUNNEL PACK, Model Number DYNJ65775A; eeee) VARITHENA PACK, Model Number DYNJ65
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023