BEUDAMED
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    cobas e801 Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022

    VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

    FDA Enforcement
    Class II ·Ongoing·ORTHO-CLINICAL DIAGNOSTICS·January 9, 2019

    Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025

    Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025

    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

    Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

    FDA Enforcement
    Class II ·Ongoing·Synthes USA HQ, Inc.·August 7, 2013

    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Corp. Hq.)·October 2, 2024