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    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Enforcement
    Class II ·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016

    Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A, EPS MB3 - ARDINT059003C, EPS MB3 TR - ARDINT059001A, EPS MB3 TR - ARDINT059001C, OPT MBAT - ARD568210010A, OPT MBAT - ARD568210010C, PWD30 DUAL - ARD267800310C, PWD30 DUAL - ARD267800330A, PWD30 DUAL - ARD267800330C, PWD30 DUAL - ARD267800340A, PWD30 DUAL - ARD267800340C, PWD30+DF - ARD268300170A, PWD30+DF - ARD568424110A, PWD30+DF - ARD568424110C, PWD30+DF - ARD568424114A, PWD30+DF - ARD568424114C, PWD30+DF - ARD568424511A, PWD30+DF - ARD568424511C, PWD30+DF - ARD568424512A, PWD30+DF - ARD568424512C, PWD30+DF - ARD568424513A, PWD30+DF - ARD568424513C, PWD30+DF - ARD568484114A, PWD30+DF - ARD568484114C, PWD30+DF - ARD569424110A, PWD30+DF - ARD569424110C, PWD30+DF - ARD569424114A, PWD30+DF - ARD569424114C, PWD30+DF - ARD569424511A, PWD30+DF - ARD569424511C, PWD30+DF - ARD569424512A, PWD30+DF - ARD569424512C, PWD30+DF - ARD569424513A, PWD30+DF - ARD569424513C, PWD30+DF - ARD569484114A, PWD30+DF - ARD569484114C, PWD30+DF - ARDPWD208008A, PWD30+DF - ARDPWD208008C, PWD30+DF - ARDPWD209000A, PWD30+DF - ARDPWD209000C, PWD30+DF - ARDPWD209009A, PWD30+DF - ARDPWD209009C, PWD30+DF - ARDPWD239013A, PWD30+DF - ARDPWD239013C, PWD30+DF - ARDPWD239014A, PWD30+DF - ARDPWD239014C, PWD30+DF - ARDPWD239015A, PWD30+DF - ARDPWD239015C, PWD30+DF - ARDPWD239031A, PWD30+DF - ARDPWD239031C, PWD30+DF - ARDPWD239032A, PWD30+DF - ARDPWD239032C, PWD30+DF - ARDPWD239033A, PWD30+DF - ARDPWD239033C, PWD30+SF - ARD568414110A, PWD30+SF - ARD568414110C, PWD30+SF - ARD568414114A, PWD30+SF - ARD568414114C, PWD30+SF - ARD568414511A, PWD30+SF - ARD568414511C, PWD30+SF - ARD568414512A, PWD30+SF - ARD568414512C, PWD30+SF - ARD568414513A, PWD30+SF - ARD568414513C, PWD30+SF - ARD568474114A, PWD30+SF - ARD568474114C, PWD30+SF - ARD569414110A, PWD30+SF - ARD569414110C, PWD30+SF - ARD569414114A, PWD30+SF - ARD569414114C, PWD30+SF - ARD569414511A, PWD30+SF - ARD569414511C, PWD30+SF - ARD569414512A, PWD30+SF - ARD569414512C, PWD30+SF - ARD569414513A, PWD30+SF - ARD569414513C, PWD30+SF - ARD569474114A, PWD30+SF - ARD569474114C, PWD30+SF - ARDPWD208009A, PWD30+SF - ARDPWD208009C, PWD30+SF - ARDPWD209001A, PWD30+SF - ARDPWD209001C, PWD30+SF - ARDPWD209002A, PWD30+SF - ARDPWD209002C, PWD30+SF - ARDPWD209010A, PWD30+SF - ARDPWD209010C, PWD30+SF - ARDPWD209011A, PWD30+SF - ARDPWD209011C, PWD30+SF - ARDPWD239016A, PWD30+SF - ARDPWD239016C, PWD30+SF - ARDPWD239017A, PWD30+SF - ARDPWD239017C, PWD30+SF - ARDPWD239018A, PWD30+SF - ARDPWD239018C, PWD30+SF - ARDPWD239034A, PWD30+SF - ARDPWD239034C, PWD30+SF - ARDPWD239035A, PWD30+SF - ARDPWD239035C, PWD30+SF - ARDPWD239036A, PWD30+SF - ARDPWD239036C, PWD30+SHIP - ARD268400080A, PWD30+SHIP - ARD268400080C, PWD33 S - ARD267800200A, PWD33 S - ARD267800200C, PWD33+DF - ARD568424710A, PWD33+DF - ARD568424710C, PWD33+DF - ARD568424714A, PWD33+DF - ARD568424714C, PWD33+DF - ARD568424751A, PWD33+DF - ARD568424751C, PWD33+DF - ARD568424752A, PWD33+DF - ARD568424752C, PWD33+DF - ARD568424753A, PWD33+DF - ARD568424753C, PWD33+DF - ARD568424755A, PWD33+DF - ARD568424755C, PWD33+DF - ARD568424758A, PWD33+DF - ARD568424758C, PWD33+DF - ARD569424710A, PWD33+DF - ARD569424710C, PWD33+DF - ARD569424714A, PWD33+DF - ARD569424714C, PWD33+DF - ARD569424751A, PWD33+DF - ARD569424751C, PWD33+DF - ARD569424752A, PWD33+DF - ARD569424752C, PWD33+DF - ARD569424753A, PWD33+DF - ARD569424753C, PWD33+DF - ARD569424755A, PWD33+DF - ARD569424755C, PWD33+DF - ARD569424758A, PWD33+DF - ARD569424758C, PWD33+SF - ARD568414710A, PWD33+SF - ARD568414710C, PWD33+SF - ARD568414714A, PWD33+SF - ARD568414714C, PWD33+SF - ARD568414751A, PWD33+SF - ARD568414751C, PWD33+SF - ARD568414752A, PWD33+SF - ARD568414752C, PWD33+SF - ARD568414753A, PWD33+SF - ARD568414753C, PWD33+SF - ARD568414755A, PWD33+SF - ARD568414755C, PWD33+SF - ARD568414758A, PWD33+SF - ARD5684147

    FDA Enforcement
    Class II ·Ongoing·Getinge Usa Sales Inc·January 24, 2024

    Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·March 18, 2026

    Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOWN,SIRUS,NONRNF,XLN/XL,20/CS, Model Number: DYNJP2002SL; 6) GOWN,NONRNF,2XL,18/CS, Model Number: DYNJP2003; 7) GOWN,SIRUS,NONRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2003S; 8) GOWN,SIRUS,NONRNF,XLN/2XL,18/CS, Model Number: DYNJP2003SL; 9) GOWN,NONRNF,3XL,18/CS, Model Number: DYNJP2004; 10) GOWN,SIRUS,NONRNF,3XL,18/CS, Model Number: DYNJP2004S; 11) GOWN,NONRNF,SM,30/CS, Model Number: DYNJP2005; 12) GOWN,SIRUS,NONRNF,SM,30/CS, Model Number: DYNJP2005S; 13) GOWN,NONRNF,4XL,18/CS, Model Number: DYNJP2009; 14) GOWN,SIRUS,NONRNF,4XL,18/CS, Model Number: DYNJP2009S; 15) GOWN,ECLIPSE,FABRNF,L,30/CS, Model Number: DYNJP2101; 16) GOWN,SIRUS,FABRNF,L,20/CS, Model Number: DYNJP2101S; 17) GOWN,ECLIPSE,FABRNF,XL,30/CS, Model Number: DYNJP2102; 18) GOWN,SIRUS,FABRNF,XL,20/CS, Model Number: DYNJP2102S; 19) GOWN,ECLIPSE,FABRNF,2XL,18/CS, Model Number: DYNJP2103; 20) GOWN,SIRUS,FABRNF,2XL,18/CS, Model Number: DYNJP2103S; 21) GOWN,ECLIPSE,POLYRNF,L,30/CS, Model Number: DYNJP2201; 22) GOWN,SIRUS,POLYRNF,SETINSLV,L,20/CS, Model Number: DYNJP2201S; 23) GOWN,ECLIPSE,POLYRNF,XL,30/CS, Model Number: DYNJP2202; 24) GOWN,SIRUS,POLYRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2202S; 25) GOWN,ECLIPSE,POLYRNF,2XL,18/CS, Model Number: DYNJP2203; 26) GOWN,SIRUS,POLYRNF,SETINSLV,2XL,18/CS, Model Number: DYNJP2203S; 27) GOWN,ECLIPSE,POLYRNF,XLN/L,28/CS, Model Number: DYNJP2204; 28) GOWN,SIRUS,POLYRNF,XLN/LG,20/CS, Model Number: DYNJP2204S; 29) GOWN,ECLIPSE,POLYRNF,XLN/XL,28/CS, Model Number: DYNJP2205; 30) GOWN,SIRUS,POLYRNF,XLN/XL,20/CS, Model Number: DYNJP2205S; 31) GOWN,ECLIPSE,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206; 32) GOWN,SIRUS,POLYRNF,XLN/2XL,18/CS, Model Number: DYNJP2206S; 33) DBQ-GOWN,PREVENTION PLUS,LN/L,ST,24/CS, Model Number: DYNJP2301P; 34) DBQ-GOWN,PREVENTION PLUS,XLN/XL,ST,24/CS, Model Number: DYNJP2302P; 35) DBD-GOWN,PREVENTION PLUS,XLN/2XL,ST,22/C, Model Number: DYNJP2303P; 36) DBD-GOWN,PREVENTION PLUS,L,ST,24/CS, Model Number: DYNJP2306P; 37) DBQ-GOWN,PREVENTION PLUS,XL,ST,24/CS, Model Number: DYNJP2307P; 38) DBQ-GOWN,PREVENTION PLUS,2XL,ST,22/CS, Model Number: DYNJP2308P; 39) GOWN,ORBIS,LVL 3,LRG/XLONG,ST,24/CS, Model Number: DYNJP2361P; 40) GOWN,ORBIS,LVL 3,XLONG/XLARGE,ST,24/CS, Model Number: DYNJP2362P; 41) GOWN,ORBIS,LVL 3,XLNG/XXLARGE,ST,22/CS, Model Number: DYNJP2363P; 42) GOWN,ORBIS,LVL 3,LARGE,ST,24/CS, Model Number: DYNJP2366P; 43) GOWN,ORBIS,LVL 3,XLARGE,ST,24/CS, Model Number: DYNJP2367P; 44) GOWN,ORBIS,LVL 3,XXLARGE,ST,22/CS, Model Number: DYNJP2368P; 45) GOWN,ORBIS,LVL 3,4XL,ST,20/CS, Model Number: DYNJP2369P; 46) GOWN,SIRUS,NONRNF,RAGLAN,L,ST,32/CS, Model Number: DYNJP2401; 47) GOWN,SIRUS,NONRNF,RAGLAN,XL,ST,30/CS, Model Number: DYNJP2402; 48) GOWN,SIRUS,NONRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2403; 49) GOWN,SIRUS,FABRNF,RAGLAN,L,ST,30/CS, Model Number: DYNJP2501; 50) GOWN,SIRUS,FABRNF,RAGLAN,XL,ST,28/CS, Model Number: DYNJP2502; 51) GOWN,SIRUS,FABRNF,RAGLAN,2XL,ST,28/CS, Model Number: DYNJP2503; 52

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