11 results
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7ms
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Sources: EU EUDAMED, US FDA
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 4, 2024
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
TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·March 10, 2021
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·December 2, 2015
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·June 11, 2014
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·June 1, 2016
Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·June 11, 2014
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·April 1, 2015
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·June 29, 2016
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016