BEUDAMED
    164 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.

    FDA Recall
    Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

    LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    FDA Enforcement
    Class II ·Terminated·DRG Instruments GmbH·August 14, 2019

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code CDZ·May 21, 2019

    CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code MOI·March 4, 2003

    96-8366 Drip Chambers, Convertible with Pierce Pin .138 Assembly; Abbott, Ashland, Ohio 44805; 650 drip chambers per case; Abbott Commodity 968366, Ashland Product #85-55960

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·June 9, 2003

    I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 86 different sets listed in the code information section below.

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FRN·June 9, 2003

    IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code LOJ·March 4, 2003

    LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port, product 19289

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FRN·May 13, 2003

    Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 22 different sets listed in the code information section below. Please Note: items p, q & r (list 191700204, 191700404 and 191700415) were packaged in kits with Sporanox Injection distributed by Ortho Biotech Products, Raritan, NJ 08869.

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·June 9, 2003

    T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·May 13, 2003

    AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0)

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code LOK·June 12, 2003

    Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·May 13, 2003

    Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·May 13, 2003

    Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information section below.

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·June 9, 2003

    Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code MOI·March 4, 2003

    Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information section below.

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·June 9, 2003