BEUDAMED
    20 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    HAMILTON-C6, REF: 160021

    FDA Enforcement
    Class II ·Ongoing·Hamilton Medical AG·May 3, 2023

    Herpes (HSV-1 & HSV-2) Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. UNIV.15DROP PUMP SET W/3 SAFELINE LL; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 362032. 2. UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; Catalog Number: 362033. 3. 60DROP METRISET PUMP SET, 3 SAFELINE; Priming volume: 19mL, length: 120in, SafeLine; Catalog Number: 362034. 4. Y TYPE BLOOD PUMP SET, SAFELINE INJ; Priming volume: 39mL, length: 120in, SafeLine¿; Catalog Number: 362043. 5. UNIV. 15 DROP PUMP SET W/ 0.2 FILTER; 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; Catalog Number: 362050. 6. SPACE PUMP SET 15 DROP W/2 SAFEDAY; SPACE PUMP SET 15 DROP W/2 SAFEDAY; Catalog Number: 362420. 7. UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL; 15 drops/mL, priming volume: 21mL, length: 120in, ULTRASITE; Catalog Number: 362431. 8. SPACE PUMP IV SET, 120 IN.; 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; Catalog Number: 362432. 9. 60 DROP METRISET PUMP SET,3 SFLINE ASV; Priming volume: 21mL, length: 121in, SafeLine; Catalog Number: 363010. 10. Y-TYPE BLOOD PUMP SET, SAFELINE, ASV; Priming volume: 40mL, length: 123in, SafeLine; Catalog Number: 363019. 11. UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV; 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; Catalog Number: 363030. 12. UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV; 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; Catalog Number: 363230. 13. Y-TYPE BLOOD PUMP SET, CARESITE, ASV; Priming volume: 41mL, length: 120in, CARESITE; Catalog Number: 363419. 14. SPACE PUMP IV SET, 2 CARESITES, ASV; 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; Catalog Number: 363420. 15. UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 363421. 16. 60DROP METRISET PUMP, 3 CARESITES, ASV; Priming volume: 21mL, length: 130in, CARESITE; Catalog Number: 363422. 17. UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV; 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; Catalog Number: 363423. 18. UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; Catalog Number: 363424. 19. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; Catalog Number: 363430. 20. UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; Catalog Number: 363433. 21. SPACE PUMP IV SET 15D, 110 IN.; "SPACE PUMP IV SET 15D, 110 IN. CLOSE"; Catalog Number: 480254. 22. SPACE PUMP IV SET, 127 IN.; SPACE PUMP IV SET, 127 IN.; Catalog Number: 480255. 23. SPACE PUMP SET 15D, CARESITE LAD 122 IN. ; 15 drops/mL, priming volume: 23mL, length: 122in, CARESITE; Catalog Number: 480256. 24. 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; Catalog Number: 480258. 25. SPACE PUMP IV SET 15D, 90 IN.; SPACE PUMP IV SET 15D, 90 IN.; Catalog Number: 480263. 26. UNIV. 15 DROP PUMP SET W 3 CARESITE L.L.; 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; Catalog Number: 490100. 27. 60 DROP METRISET PUMP SET, 3 CARESITES; Priming volume: 19mL, length: 120in, CARESITE; Catalog Number: 490101.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

    FDA Enforcement
    Class II ·Ongoing·Diasorin Inc.·January 31, 2024

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·August 31, 2022

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·March 31, 2021

    Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363420

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363030

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 363230

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363421

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363433

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·July 24, 2024

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    FDA Enforcement
    Class II ·Ongoing·UFSK - International OSYS Gmbh·July 26, 2023

    Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS ACCESS PACK m. VASCULAR ACCESS PACK n. ARTERIOGRAM PACK o. AV FISTULA/GRAFT INSER PK p. VEIN ABLATION PACK q. PORT PACK r. MINOR VASCULAR s. FISTULA PACK t. AV FISTULA-LF u. AV FISTULA v. PORT VENOUS ACCESS w. AV FISTULA

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 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