BEUDAMED
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    BD Vacutainer Urine Collection Cups, Cat. No. 364941

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 28, 2018

    BD Vacutainer Specimen Collection Cups, Cat. No. 364975

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 28, 2018

    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 15, 2017

    KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 28, 2018

    KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·November 28, 2018

    MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

    FDA Enforcement
    Class II ·Ongoing·Unetixs Vascular, Inc.·March 8, 2023

    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.

    FDA Enforcement
    Class II ·Terminated·Horiba Instruments, Inc dba Horiba Medical·July 4, 2018

    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.

    FDA Enforcement
    Class II ·Terminated·C P Medical, Inc.·November 5, 2014

    Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·May 10, 2023

    VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 27, 2013

    Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·May 10, 2023

    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

    FDA Enforcement
    Class II ·Terminated·Inpeco S.A.·May 16, 2018

    Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

    Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·October 20, 2021

    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

    Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·June 16, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·June 16, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·June 16, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·June 16, 2021