BEUDAMED
    200 results · 28ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Spine Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Cataract Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Hand Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Gyn Laparoscopy convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Biopsy Drape Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    American Contract Systems Special Procedure Pack convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·August 14, 2024

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item Number HSCY13M; 5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K; 6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H; 7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D; 8) PDA LF SJW, Model/Item Number SWPD12K; 9) AAA PACK - 206038, Model/Item Number UDAA63AH; 10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF; 11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX; 12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD; 13) PROCUREMENT PACK, Model/Item Number UIPC89D; 14) THYROID PACK (PS 096552), Model/Item Number UITR45W; 15) TRAUMA PACK 175634, Model/Item Number UMTR17B; 16) TRAUMA PACK 175634, Model/Item Number UMTR17C.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020