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

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    CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·November 2, 2022

    Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC24130ST/D, 28MC24130ST-W/A, 28MC2415045/D, 28MC24150ST/D, 28MC24150ST/F, 28MC28110ST/D, 28MC2813045/D, 28MC28130SN/D, 28MC28130SN/F, 28MC28130ST/D, 28MC28150SN/D, 28MC28150SN/F, 29MC2911045/D, 29MC29130SN/F, 29MC29130ST/D, 29MC29150ST/CNB, 29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·January 10, 2024

    Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·November 26, 2025

    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA1864; d. BLOCK KIT, Model Number: DYNJRA1893; e. DR LEWIS US TRAY, Model Number: DYNJRA1998; f. ECHOGENIC SINGLE SHOT TRAY, Model Number: DYNJRA1978, DYNJRA1978A, SAMPA0109; g. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739A; h. NERVE BLOCK INSERTION, Model Number: DYNJRA2027; i. NERVE BLOCK PREP TRAY, Model Number: DYNJRA1837; j. NERVE BLOCK TRAY, Model Number: DYNJRA1878, DYNJRA1900; k. NERVE PERIPHERAL PACK, Model Number: DYNJRA2055; l. PAIN BLOCK TRAY, Model Number: DYNJRA0827A; m. PAIN PREP TRAY W/PROBE COVER, Model Numbers: DYNJRA0881, DYNJRA1847, DYNJRA1975; n. PAIN PREP W/ PROBE COVER TRAY, Model Number: DYNJRA2028; o. PAIN PREP W/PROBE COVER TRAY, Model Number: PAIN1762; p. PAIN TRAY, Model Number: DYNJRA1603; q. PERIPHERAL NERVE CATHETER KT, Model Number: PAIN1560; r. PREOP NERVE BLOCK TRAY, Model Number: DYNJRA2040; s. PREP TRAY, Model Number: DYNJRA1498A; t. SINGLE SHOT BLOCK, Model Number: DYNJRA0961B; u. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA2077; v. TAP BLOCK, Model Number: DYNJRA1823; w. TRAY ULTRASOUND BLOCK 20G X 4, Model Number: DYNJRA9044; x. TRAY 18G CPNB 20G STYLETED, Model Number: DYNJRA9040; y. ULTRASOUND TRAY, Model Number: DYNJRA2022; z. US TPI KIT, Model Number: DYNJRA1945

    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) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881A; e) PAIN TRAY, Model Number DYNJRA1603; f) FEMORAL BLOCK TRAY, Model Number DYNJRA1739A; g) TAP BLOCK, Model Number DYNJRA1823; h) NERVE BLOCK PREP TRAY, Model Number DYNJRA1837; i) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1847; j) ANESTHESIA BLOCK PACK - TBR, Model Number DYNJRA1864; k) 18G CPNB 20G STYLETED CATHETER, Model Number DYNJRA1869; l) NERVE BLOCK TRAY, Model Number DYNJRA1878; m) BLOCK KIT, Model Number DYNJRA1893; n) NERVE BLOCK TRAY, Model Number DYNJRA1900; o) US TPI KIT, Model Number DYNJRA1945; p) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1975; q) DR LEWIS US TRAY, Model Number DYNJRA1998; r) ULTRASOUND GUIDED NERVE BLOCK, Model Number DYNJRA2013; s) ULTRASOUND TRAY, Model Number DYNJRA2022; t) NERVE BLOCK INSERTION, Model Number DYNJRA2027; u) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028; v) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028A; w) PAIN TRAY, Model Number DYNJRA2041; x) SUPPORT TRAY, Model Number DYNJRA2044; y) SUPERFICIAL NERVE BLOCK, Model Number DYNJRA2086; z) NERVE BLOCK TRAY, Model Number DYNJRA2148; aa) TRAY 18G CPNB 20G STYLETED, Model Number DYNJRA9040; bb) ULTRASOUND BLOCK TRAY, Model Number DYNJRA9044; cc) PERIPHERAL NERVE CATHETER KT, Model Number PAIN1560; dd) PAIN PREP W/PROBE COVER TRAY, Model Number PAIN1762

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023

    MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869; 6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035; 7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040; 8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O; 9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C; 10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B; 11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C; 12) CONTINUOUS EPIDURAL, REF PAIN1271A; 13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B; 14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317; 15) 20G CONT. EPID TRAY, REF PAIN1353B; 16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358; 17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361; 18) JHAC CONT EPIDURAL, REF PAIN1437A; 19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B; 20) EPIDURAL CATH KIT, REF PAIN1536A; 21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547; 22) EPIDURAL TRAY, REF PAIN1558; 23) CONTINUOUS EPIDURAL, REF PAIN1581A; 24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A; 25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B; 26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A; 27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636; 28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A; 29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A; 30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709; 31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A; 32) CONTINUOUS EPIDURAL, REF PAIN1766A; 33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806; 34) EPIDURAL TRAY IMF 103130, REF PAIN1807; 35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816; 36) CONTINUOUS EPIDURAL, REF PAIN1844; 37) CSE TRAY, REF PAIN1845; 38) BWH L&D EPIDURAL KIT, REF PAIN1846; 39) 17G CONT. EPI - MRI SAFE, REF PAIN1854; 40) 17G L&D CONT. EPIDURAL, REF PAIN1855; 41) CONTINUOUS/CSE TRAY, REF PAIN1856; 42) CONTINUOUS/CSE TRAY, REF PAIN1856A; 43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864; 44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A; 45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878; 46) CSE TRAY, REF PAIN1885; 47) TEAM HEALTH EPIDURAL, REF PAIN1887; 48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888; 49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890; 50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892; 51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893; 52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894; 53) CSE TRAY, REF PAIN1898; 54) CSE TRAY, REF PAIN1904; 55) 17/25G CSE TRAY, REF PAIN1919; 56) CSE TRAY, REF PAIN1920; 57) 17/25G CSE TRAY, REF PAIN1937; 58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940; 59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958; 60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967; 61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014; 62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025; 63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026; 64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028; 65) 17G CONT EPIDURAL NYLON, REF PAIN9030; 66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031; 67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034; 68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035; 69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036; 70) REINIF 19G EPI CATH S STERILE, REF REPICATH19; 71) CONT. EPIDURAL TRAY, REF SAMPA0105; 72) EPIDURAL CATH PACK, REF SAMPA0106; 73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110; 74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 4, 2024