BEUDAMED
    25 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·April 3, 2013

    AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·November 15, 2023

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

    FDA Enforcement
    Class II ·Ongoing·LTS Therapy Systems, LLC·August 6, 2025