BEUDAMED
    15 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·January 17, 2024

    PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1

    FDA Enforcement
    Class II ·Terminated·Prytime Medical Devices, Inc.·February 17, 2021

    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·September 26, 2012

    Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·September 26, 2012

    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW

    FDA Enforcement
    Class II ·Terminated·GN Hearing A/S·December 4, 2019

    Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]

    FDA Enforcement
    Class II ·Ongoing·Draeger Medical Systems, Inc.·June 28, 2023

    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 14, 2015

    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

    FDA Enforcement
    Class II ·Terminated·Neocis, Inc.·February 3, 2021

    DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    FDA Enforcement
    Class II ·Terminated·Neocis Inc.·July 22, 2020

    DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    FDA Enforcement
    Class II ·Terminated·Neocis Inc.·July 22, 2020

    DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    FDA Enforcement
    Class II ·Terminated·Neocis Inc.·July 22, 2020

    SafeDAY set 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 number: 1. IV ADM SET 15 DR W/2 SAFEDAY & STOPCOCK; Catalog Number: 352646.

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

    BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, MEDBANK MINI 2FH/ 169-104, MEDBANK MINI 2FM/ 169-105, MEDBANK MINI 2HH-1FH/ 169-106, MEDBANK MINI 2HH-1FM/ 169-107, MEDBANK MINI 2HH-1FM MEDPASS/ 169-152, MEDBANK MINI 2HH-2HM/ 169-108, MEDBANK MINI 2HM-1FM/ 169-109, MEDBANK MINI 3HH-1FG/ 169-110, MEDBANK MINI 3HH-1HM/ 169-111, MEDBANK MINI 4HH/ 169-112, MEDBANK MINI 4HH MEDPASS/ 169-150, MEDBANK MINI 4HM/ 169-113, MEDBANK MINI CR-2HH-1FH-P/ 169-114, MEDBANK MINI CR-4HH-P/ 169-115, MB MINI MAIN CR/ 169-163, MB MINI MAIN W/CUBIE DRWS/ 169-159, MB MINI MAIN W/FH FALSE DRW/ 169-162, MB MINI MAIN W/HH FALSE DRW/ 169-161, MB MINI MAIN W/MATRIX DRWS / 169-160, MB MINI MAIN W/MP/ 169-164 Used with the following user guides: BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989), BD Pyxis MedBank Cabinet User Guide (DIR 10000414987), BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990)

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·July 10, 2024

    IV Administration Set 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 number: 1. IV ADMIN SET 15 DR W/2 SAFEDAY; Catalog Number: 352636. 2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639. 3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640. 4. IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643. 5. IV ADMIN SET, 105 IN.; Catalog Number: 477003. 6. IV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006. 7. IV ADMIN SET, 121 IN.; Catalog Number: 477008. 8. IV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012. 9. IV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019. 10. IV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021. 11. IV ADMIN SET 114 IN.; Catalog Number: 477022. 12. IV ADMIN SET 5 CARESITE LADS, 126 IN.; Catalog Number: 477023. 13. IV SET 15DR 3 SAFEDAY, 106 IN.; Catalog Number: 477053. 14. IV ADMIN SET, 15DR, CARESITE LAD, 121 IN; Catalog Number: 490513. 15. IV ADMIN SET, 15D, 120 IN.; Catalog Number: 490521. 16. IV ADMIN SET 15D 2 CARESITE LADS, 112IN.; Catalog Number: 490527. 17. IV ADMIN SET 15 DRP CARESITE SAFEPORT; Catalog Number: 490529. 18. IV ADMIN SET, 15D, 139 IN.; Catalog Number: 490535. 19. IV ADMIN SET 15D, CARESITE LAD, 122IN.; Catalog Number: 490543. 20. IV ADMIN SET 15D 3 CARESITE LADS, 150IN.; Catalog Number: 490546. 21. IV ADMIN SET, 125 IN.; Catalog Number: 490547. 22. IV ADMIN SET 15D, 5 CARESITE INJ, 150in.; Catalog Number: 490552. 23. IV ADMIN SET, 120IN.; Catalog Number: 490553. 24. IV ADMIN SETW/ B/C VLV 3 CARESITE 134IN.; Catalog Number: 490554. 25. IV ADMIN SET 15DR w/3 B/C VLV, 124 IN.; Catalog Number: 490555. 26. IV ADMIN SET 15D w/B/C VLV, 139 IN.; Catalog Number: 490558. 27. IV ADMINISTRATION SET, 117 IN.; Catalog Number: 490559. 28. IV ADMINISTRATION SET, 108 IN.; Catalog Number: 490560. 29. IV ADMINISTRATION SET, 134 IN.; Catalog Number: 490561. 30. IV ADMIN SET 15D w/B/C VLV, 140 IN.; Catalog Number: 490562. 31. IV ADMIN SET, 111 IN.; Catalog Number: 490563. 32. IV ADMIN SET 15D 2 CARESITE LADS, 122 IN; Catalog Number: 490569. 33. IV ADMIN SET 15D STOPCOCK, DUAL MANIFOLD; Catalog Number: 490573. 34. IV ADMIN SET 15D w/B/C VLV, 110 IN.; Catalog Number: 490574. 35. IV ADMIN 15D 5 CARESITE LADS STPCK 120in; Catalog Number: 490575. 36. IV ADMIN SET 15D 5 CARESITE LADS, 140 IN; Catalog Number: 490578. 37. IV ADMIN SET W/15D, 4 CARESITE LADS; Catalog Number: 490581. 38. IV ADMIN 15D CARESITE LADS, STPCK 134 IN; Catalog Number: 490582. 39. IV ADMIN SET, 15D, 108 IN.; Catalog Number: 490583. 40. IV ADMIN SET, 10 DROP, 130 IN.; Catalog Number: 490588. 41. IV ADMIN SET, 132 IN.; Catalog Number: 490589. 42. IV ADMIN SET, 15DR, 105 IN.; Catalog Number: 490600. 43. IV ADMIN SET,3 CARESITE,3 HF SPCK, 129IN; Catalog Number: 490607. 44. IV SET 15DR 3CARESITE 2STOPCOCK, 126IN; Catalog Number: 490608. 45. IV ADMIN SET 15D 2 CARESITE LADS, 138 IN; Catalog Number: 490615. 46. IV SET 15DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490618. 47. IV SET 60DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490619. 48. IV ADMIN SET 15 DRPS 4W STOPCOCK W/ C&S; Catalog Number: 490644. 49. IV ADMIN SET 15 DRPS ULTRAP. ZERO 90.6IN; Catalog Number: 490657. 50. IV ADMIN SET 15 DRPS STOPCOCK MALE 117IN; Catalog Number: 490658.

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

    MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1FH- 1HM, REF: 169-101; BD PYXIS MEDBANK MINI 1HH-1HM- 1FM, REF: 169-102; BD PYXIS MEDBANK MINI 1HH-3HM, REF: 169-103; BD PYXIS MEDBANK MINI 2FH, REF: 169-104; BD PYXIS MEDBANK MINI 2FM, REF: 169-105; BD PYXIS MEDBANK MINI 2HH-1FH, REF: 169-106; BD PYXIS MEDBANK MINI 2HH-1FM , REF: 169-107; BD PYXIS MEDBANK MINI 2HH-2HM, REF: 169-108; BD PYXIS MEDBANK MINI 2HM-1FM, REF: 169-109; BD PYXIS MEDBANK MINI 3HH-1FG, REF: 169-110; BD PYXIS MEDBANK MINI 3HH-1HM, REF: 169-111; BD PYXIS MEDBANK MINI 4HH, REF: 169-112; BD PYXIS MEDBANK MINI 4HM, REF: 169-113; BD PYXIS MDBANK TWR MN 7HH-1HM-3FM RxNow, REF: 169-132; BD PYXIS MEDBANK MINI 1FH-1FM, REF: 169-137; BD PYXIS MEDBANK TWR MN 1FH- 10HM-1FM, REF: 169-138; BD PYXIS MEDBANK TWR MN 2HH- 4FH-2FM, REF: 169-139; OBS BD PYXIS MB TOWER MAIN, REF: 169-153; OBS BD PYXIS MB TWR RXNOW MAIN W/MED PRI, REF: 169-155; OBS BD PYXIS MB TWR RXNOW MAIN W/PAT PRI, REF: 169-156; OBS BD PYXIS MB MINI MAIN W/CUBIE DRWS, REF: 169-159; OBS BD PYXIS MB MINI MAIN W/MATRIX DRWS, REF: 169-160; OBS BD PYXIS MB MINI MAIN W/HH FALSE DRW, REF: 169-161; OBS BD PYXIS MB MINI MAIN W/FH FALSE DRW, REF: 169-162; BD PYXIS MEDBANK TWR MN 10HH- 1FH-1FM, REF: 169-23; BD PYXIS MEDBANK TWR MN 10HH- 2FH, REF: 169-24; BD PYXIS MEDBANK TWR MN 10HH- 2FM, REF: 169-25; BD PYXIS MEDBANK TWR MN 12HH- 1FF, REF: 169-26; BD PYXIS MEDBANK TWR MN 12HH- 1FH, REF: 169-27; BD PYXIS MEDBANK TWR MN 12HH- 1FM, REF: 169-28; BD PYXIS MEDBANK TWR MN 14HH, REF: 169-29; BD PYXIS MEDBANK TWR MN 1HH- 1HM-2FM-4FF, REF: 169-30; BD PYXIS MEDBANK TWR MN 2FH- 2HM-4FM, REF: 169-31; BD PYXIS MEDBANK TWR MN 2HH- 10HM-1FM, REF: 169-32; BD PYXIS MEDBANK TWR MN 2HH- 1FH-5FM, REF: 169-33; BD PYXIS MEDBANK TWR MN 2HH- 2FH-4FM, REF: 169-34; BD PYXIS MEDBANK TWR MN 2HH- 2FM-4FF, REF: 169-35; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FF, REF: 169-36; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FM, REF: 169-37; BD PYXIS MEDBANK TWR MN 2HH- 6FM, REF: 169-38; BD PYXIS MEDBANK TWR MN 2HH- 6HM-3FM, REF: 169-39; BD PYXIS MEDBANK TWR MN 2HH- 8HM-2FM, REF: 169-40; BD PYXIS MEDBANK TWR MN 2HM- 6FM, REF: 169-41; BD PYXIS MEDBANK TWR MN 3FH-4FM , REF: 169-42; BD PYXIS MEDBANK TWR MN 3HH- 7HM-2FM, REF: 169-43; BD PYXIS MEDBANK TWR MN 4HH- 10HM, REF: 169-44; BD PYXIS MEDBANK TWR MN 4HH- 1FH-2HM-3FM, REF: 169-45; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4FM, REF: 169-46; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4HM-2FM, REF: 169-47; BD PYXIS MEDBANK TWR MN 4HH- 1FH-6HM-1FM, REF: 169-48; BD PYXIS MEDBANK TWR MN 4HH- 2FH-2HM-2FM, REF: 169-49; BD PYXIS MEDBANK TWR MN 4HH- 2FH-3FM, REF: 169-50; BD PYXIS MEDBANK TWR MN 4HH- 2HM-4FM, REF: 169-51; BD PYXIS MEDBANK TWR MN 4HH- 3FH-2FM, REF: 169-52; BD PYXIS MEDBANK TWR MN 4HH- 4FH-1FM, REF: 169-53; BD PYXIS MEDBANK TWR MN 4HH- 4HM-3FM, REF: 169-54; BD PYXIS MEDBANK TWR MN 4HH-5FH, REF: 169-55; BD PYXIS MEDBANK TWR MN 4HH- 5FM, REF: 169-56; BD PYXIS MEDBANK TWR MN 4HH- 6HM-2FM, REF: 169-57; BD PYXIS MEDBANK TWR MN 4HH- 8HM-1FM, REF: 169-58; BD PYXIS MEDBANK TWR MN 4HM- 5FM, REF: 169-59; BD PYXIS MEDBANK TWR MN 5HH- 3HM-3FM, REF: 169-60; BD PYXIS MEDBANK TWR MN 5HH- 9HM, REF: 169-61; BD PYXIS MEDBANK TWR MN 6FH-1FM, REF: 169-62; BD PYXIS MEDBANK TWR MN 6HH- 1FH-2HM-2FM, REF: 169-63; BD PYXIS MEDBANK TWR MN 6HH- 1FH-3FM, REF: 169-64; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2FM, REF: 169-65; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2HM-1FM, REF: 169-66; BD PYXIS MEDBANK TWR MN 6HH-4FH, REF: 169-67; BD PYXIS MEDBANK TWR MN 6HH- 4FM, REF: 169-68; BD PYXIS MEDBANK TWR MN 6HH- 4HM-2FM, REF: 169-69; BD PYXIS MEDBANK TWR MN 6HH- 6HM-1FM, REF: 169-70; BD PYXIS MEDBANK TWR MN 6HH- 8HM, REF: 169-71; BD PYXIS MEDBANK TWR MN 7FH, REF: 169-72; BD PYXIS M

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·April 23, 2025