10 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
FDA Enforcement
Class II
·Ongoing·Canon Medical System, USA, INC.·September 2, 2020
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model Number DYNJ906440A; e) CABG, Model Number DYNJ906878A; f) VALVE, Model Number DYNJ906882A; g) VASCULAR, Model Number DYNJ906883A; h) DR WILLIAMS HEART, Model Number DYNJ907552A; i) PUH PERCUTANEOUS ECMO, Model Number DYNJ907554C; j) TAVR, Model Number DYNJ907561A; k) TAVR, Model Number DYNJ907561B; l) TAVR, Model Number DYNJ907561C; m) OPEN HEART CDS, Model Number DYNJ907607A; n) OPEN HEART CDS, Model Number DYNJ907607B; o) OPEN HEART CDS, Model Number DYNJ907607C; p) OPEN VASCULAR UE, Model Number DYNJ907858A; q) PACEMAKER, Model Number DYNJ907907; r) DEBOER HEART, Model Number DYNJ907914A; s) DEBOER HEART, Model Number DYNJ907914B; t) DEBOER HEART, Model Number DYNJ907914C; u) GENERAL HEART, Model Number DYNJ907915; v) AV FISTULA, Model Number DYNJ907975; w) AV FISTULA, Model Number DYNJ907975A; x) AV FISTULA, Model Number DYNJ907975B; y) SAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B; z) CARDIAC CABG B, Model Number DYNJ908121B; aa) OPEN HEART LINE SET UP, Model Number DYNJ908179A; bb) STEWARD VASCULAR SAS, Model Number DYNJ908563; cc) TAVR, Model Number DYNJ908646; dd) TAVR, Model Number DYNJ908646A; ee) ENDOVASCULAR, Model Number DYNJ908880; ff) ENDOVASCULAR, Model Number DYNJ908880A; gg) VASCULAR, Model Number DYNJ909091; hh) ENDOVASCULAR, Model Number DYNJ909253; ii) TAVR, Model Number DYNJ909270; jj) CABG, Model Number DYNJ9372030G; kk) OPEN HEART, Model Number DYNJ9718008AS; ll) ADULT CORONARY PACK, Model Number DYNJV0275M; mm) RADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A; nn) VASCULAR PACK, Model Number DYNJVB1307; oo) VASCULAR PACK, Model Number DYNJVB1307A; pp) VASCULAR EXTREMITY PPS, Model Number DYNJVB91063C; qq) ENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067; rr) PERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A; ss) VEIN PACK-LF, Model Number PHS151095000; tt) E P PACK-LF, Model Number PHS41732B; uu) PICC VASCULAR ACCESS PACK, Model Number PICCNC0010; vv) TVS4000 ENDOVENOUS PACK, Model Number TVS4000L;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
ALTRUA 2 DR Pacemaker
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 24, 2018
Model Number S702, ALTRUA 2 DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number S722, ALTRUA 2 DR EL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pacemaker, Model Number L201; 9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209; 10. PROPONENT SR SL Pacemaker, Model Number L210; 11. PROPONENT DR SL MRI Pacemaker, Model Number L211; 12. PROPONENT DR EL Pacemaker, Model Number L221; 13. PROPONENT DR EL MRI Pacemaker, Model Number L231*; 14. ACCOLADE SR SL Pacemaker, Model Number L300; 15. ACCOLADE DR SL Pacemaker, Model Number L301; 16. ACCOLADE SR SL MRI Pacemaker, Model Number L310; 17. ACCOLADE DR SL MRI Pacemaker, Model Number L311; 18. ACCOLADE DR EL Pacemaker, Model Number L321; 19. ACCOLADE DR EL MRI Pacemaker, Model Number L331*; 20. ALTRUA 2 SR SL Pacemaker, Model Number S701; 21. ALTRUA 2 DR SL Pacemaker, Model Number S702; 22. ALTRUA 2 DR EL Pacemaker, Model Number S722.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·May 6, 2026
Custodiol HTK Solution, 500ml bottle. 10 per carton.
FDA Enforcement
Class II
·Ongoing·Dr Franz Koehler Chemie Gmbh·October 2, 2024
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK, Model Number: DYNJ65027B; 7) VASCULAR PACK-LF, Model Number: DYNJ48196C; 8) IMPLANT PACK, Model Number: DYNJ40480; 9) OPEN HEART, Model Number: DYNJ900523B; 10) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 11) CHOG VP SHUNT PACK, Model Number: SYNJ10280C; 12) VASCULAR PACK-LF, Model Number: DYNJ48196C; 13) EP PACK-LF, Model Number: DYNJ27949F; 14) PACEMAKER PACK WRO-LF, Model Number: DYNJ41874C; 15) CARDIAC PACK OPTION 1, Model Number: DYNJ83208A; 16) EP DRAPE PACK, Model Number: DYNJ56729; 17) CSTM EP PACEMAKER DRAPE PACK, Model Number: DYNJCD0326; 18) MINOR INTERVENTIONAL TRAY, Model Number: DYNJ80084; 19) CT PACK, Model Number: DYNJ39111A; 20) VASCULAR PACK-LF, Model Number: DYNJ25102I; 21) VASCULAR ACCESS PROCEDURE PACK, Model Number: DYNJ62339; 22) ANGIO TRAY, Model Number: DYNJ43278C; 23) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 24) E.P. BASIC PACK-LF, Model Number: DYNJ24735F; 25) PORT A CATH PACEMAKER BJC-LF, Model Number: DYNJ41683B; 26) PACEMAKER PACK, Model Number: DYNJ39379C; 27) VEIN PACK, Model Number: DYNJ64016B; 28) EP PACK, Model Number: DYNJ68019A; 29) ENDOVENOUS BASIC PACK, Model Number: DYNJ69108A; 30) PACEMAKER PACK-LF, Model Number: DYNJHTCLP101A; 31) EP PACK, Model Number: DYNJ38147C; 32) HEART PRCMNT CHOICE, Model Number: DYNDA1841; 33) PACEMAKER PACK SMGH-LF, Model Number: DYNJ41925I; 34) EP PACK, Model Number: DYNJ81951B; 35) HEALTH ALL VASCULAR PACK-LF, Model Number: DYNJ19538F; 36) OPEN HEART, Model Number: CDS982026V; 37) OPEN HEART, Model Number: CDS982026V
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 23, 2025
Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NERVE BLOCK ACCESSORY PACK, Pack Number DYNJ0134147D ; 7) UNIVERSAL PROC TRAY-LF, Pack Number DYNJ02120B ; 8) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AJ; 9) CUSTOM BLOCK KEMP PACK-LF , Pack Number DYNJ0371999G ; 10) PAIN MANAGEMENT PACK-LF , Pack Number DYNJ0374104F ; 11) THORASCOPIC - UNIV, Pack Number DYNJ0375880O ; 12) ANGIOGRAPHIC PACK II-LF , Pack Number DYNJ0543507AB; 13) GM ANGIOGRAPHY PACK-LF, Pack Number DYNJ0621584Y ; 14) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0689247S ; 15) PERI NEURO BLOCK PACK-LF, Pack Number DYNJ0703127A ; 16) MAJOR HEAD/NECK PACK-LF , Pack Number DYNJ0826705L ; 17) STANDARD BLOCK PACK-LF, Pack Number DYNJ0957047C ; 18) STANDARD BLOCK PACK-LF, Pack Number DYNJ0957047CH; 19) NECK PACK , Pack Number DYNJ17213C ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ20085K ; 21) ANGIO CATH PACK-MARY IMMACULAT, Pack Number DYNJ24517D ; 22) PAIN MANAGEMENT , Pack Number DYNJ26879A ; 23) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJ32412B ; 24) UNIVERSAL BLOCK TRAY, Pack Number DYNJ32680; 25) ANGIOGRAM TRAY, Pack Number DYNJ33638J ; 26) NERVE BLOCK PACK-LF , Pack Number DYNJ34351B ; 27) PATIENT PREP TRAY , Pack Number DYNJ34489C ; 28) UNIVERSAL MAJOR PACK-LF , Pack Number DYNJ35760B ; 29) BLOCK-LF, Pack Number DYNJ36152A ; 30) TRANSFORAMINAL PACK , Pack Number DYNJ36406B ; 31) UNIVERSAL BLOCK TRAY, Pack Number DYNJ36781; 32) RADIOFREQUENCY PACK , Pack Number DYNJ37338C ; 33) MAJOR NEURO VCH , Pack Number DYNJ39218D ; 34) NEPHROSTOMY PACK, Pack Number DYNJ41069A ; 35) CVOR ANGIOGRAPHY PACK-LF, Pack Number DYNJ42367B ; 36) BLOCK PACK, Pack Number DYNJ44205C ; 37) NECK PACK-LF, Pack Number DYNJ46059A ; 38) UNIVERSAL RVHS-LF , Pack Number DYNJ46874; 39) BLOCK KIT-LF, Pack Number DYNJ47338; 40) ANGIO KIT , Pack Number DYNJ48177A ; 41) UNIVERSAL CORE DR RUNNELS PACK, Pack Number DYNJ52230; 42) ANGIO PACK-LF , Pack Number DYNJ52898B ; 43) NEPHROLOGY PACK , Pack Number DYNJ59089; 44) MAJOR ANGIO , Pack Number DYNJ59301A ; 45) NIJHER PAIN PACK, Pack Number DYNJ62009C; 46) NIJHER PAIN PACK, Pack Number DYNJ62009C ; 47) O NEILL PAIN PACK , Pack Number DYNJ62011C ; 48) NEPHROLOGY PACK , Pack Number DYNJ62930; 49) NEPHROLOGY PACK , Pack Number DYNJ63200A ; 50) NEURO GOODIE PACK - DUNN, Pack Number DYNJ64570; 51) THROMBECTOMY PACK - NEUROS, Pack Number DYNJ64580; 52) RADIOFREQUENCY, Pack Number DYNJ68289; 53) EPIDURAL PACK, Pack Number DYNJ68840A; 54) EPIDURAL PACK , Pack Number DYNJ68840A ; 55) NEURO , Pack Number DYNJ901405K; 56) NEURO LUMBAR, Pack Number DYNJ904111G; 57) NERVE BLOCK TRAY-LF , Pack Number DYNJRA0022A; 58) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0031B; 59) UNIVERSAL BLOCK PAIN PK , Pack Number DYNJRA0041 ; 60) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044 ; 61) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044A; 62) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0044B; 63) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0050A; 64) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0051B; 65) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0052 ; 66) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0087B; 67) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0104B; 68) UNIVERSAL BLOCK SPINAL-LF , Pack Number DYNJRA0105B; 69) UNIVERSAL BLOCK TRAY-LF, Pack Number DYNJRA0110A; 70) UNIVERSAL BLOCK TRAY-LF, Pack Number DYNJRA0111; 71) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0139D; 72) PAIN CLINIC , Pack Number DYNJRA0173B; 73) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0179 ; 74) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0186C; 75) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0187B; 76) UNIVERSAL BLOCK TRAY-LF , Pack Number DYNJRA0191C; 77) NERVE BLOCK TRAY (FACET)-LF , Pack Number DYNJRA0207A; 78) NERVE
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024