BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLOGY PACK l. OCULOPLASTIC PACK m. BLEPH PACK n. EYE PACK o. OCULAR PLASTIC PACK p. OCULOPLASTIC PACK

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

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    FDA Enforcement
    Class II ·Ongoing·IDS LTD·January 15, 2025

    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