BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

    FDA Enforcement
    Class II ·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019

    AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

    FDA Enforcement
    Class II ·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019

    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·May 10, 2017

    Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

    FDA Enforcement
    Class II ·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019

    COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 1, 2016

    Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.

    FDA Enforcement
    Class II ·Terminated·Alere San Diego, Inc.·June 5, 2013

    a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004

    FDA Enforcement
    Class II ·Ongoing·Princeton Biomeditech Corp·November 6, 2024

    SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025

    Lem Fertility hCG Pregnancy Urine Test REF 100-12

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023