BEUDAMED
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    AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Ansh Labs, LLC·January 20, 2021

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Enforcement
    Class II ·Terminated·On-X Life Technologies, Inc.·February 1, 2017

    Bedside PICC CDS Convenience Kit

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OEZ·October 27, 2021

    Neuro Convenience Kit

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OJG·October 27, 2021

    Major Vascular CDS Convenience Kit

    FDA Recall
    Terminated ·Medline Industries Inc·Product code LRO·October 27, 2021

    Venous Access Pack-LF Convenience Kit

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OFF·October 27, 2021

    EVLP Convenience Pack/Kit

    FDA Recall
    Terminated ·Medline Industries Inc·Product code LRO·October 27, 2021

    Outlook Pump Set w/150 ml Burette w/15um Filter & Inj Site, Check Valve, 2 Inj Sites, 120 in V7421M

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Safesite Inj Sites, Check Valve 120 in SS3115M

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasite Inj Sites, 120 in US3121M

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009

    Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·June 30, 2008

    Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog number 375113. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·June 30, 2008

    Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FRN·June 30, 2008

    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·July 16, 2014

    REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 13, 2020

    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·May 29, 2014

    Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um Filter, Spin Lock Connector, 120 in US3112F

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FPA·November 24, 2009