4 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·October 16, 2013
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·November 21, 2018
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040; 6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097; 7) PAIN TRAY, Pack Number DYNJRA2230; 8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A; 9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856; 10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A; 11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047; 12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 14, 2024
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND GUIDED NERVE BLOCK, Medline Kit SKU DYNJRA2013; 5) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2017; 6) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067; 7) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067A; 8) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2093; 9) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117A; 10) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124; 11) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124A; 12) PAIN TRAY, Medline Kit SKU DYNJRA2144; 13) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2221; 14) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2333; 15) SPINAL TRAY, Medline Kit SKU DYNJRA2390; 16) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2402; 17) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407; 18) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407A; 19) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407B; 20) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447; 21) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447A; 22) SPINAL TRAY 25G, Medline Kit SKU DYNJRA2488A; 23) J&S SPINAL TRAY, Medline Kit SKU DYNJRA2545; 24) SPINAL TRAY, Medline Kit SKU DYNJRA2549; 25) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2550; 26) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2552; 27) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554; 28) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554A; 29) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2578; 30) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2588; 31) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2602; 32) SPINAL TRAY, Medline Kit SKU DYNJRA2618; 33) SPINAL TRAY, Medline Kit SKU DYNJRA2619; 34) SPINAL TRAY, Medline Kit SKU DYNJRA2622; 35) SPINAL BLOCK 25 WHITACRE 5S ND, Medline Kit SKU DYNJRA2624; 36) SPINAL TRAY, Medline Kit SKU DYNJRA2631; 37) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2632; 38) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2633; 39) SPINAL TRAY, Medline Kit SKU DYNJRA2645; 40) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2654; 41) CSE PAIN MANAGEMENT TRAY, Medline Kit SKU DYNJRA2665; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2667; 43) SPINAL TRAY 24G BD, Medline Kit SKU DYNJRA2675; 44) SPINAL TRAY W/ CHLORAPREP, Medline Kit SKU DYNJRA2680; 45) SPINAL TRAY, Medline Kit SKU DYNJRA2682; 46) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2684; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2725; 48) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2757; 49) TRAY, 25G SPINAL W/RX DURAPREP, Medline Kit SKU DYNJRA9039; 50) TRAY, 25G SPINAL W/RX, Medline Kit SKU DYNJRA9045; 51) SLSYSTEM CSE TRAY, Medline Kit SKU PAIN2333; 52) 25G SPINAL BLOCK TRAY, Medline Kit SKU SAMPA0135.
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·June 3, 2026