BEUDAMED
    60 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 ×

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·November 16, 2016

    e-fix E20 power drive. The product is a wheelchair component/accessory.

    FDA Recall
    Terminated ·Frank Mobility Systems, Inc.·Product code ITI·August 1, 2004

    e-fix E19 power drive. The product is a wheelchair component/accessory.

    FDA Recall
    Terminated ·Frank Mobility Systems, Inc.·Product code ITI·August 1, 2004

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 21, 2016

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·August 24, 2016

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·March 24, 2016

    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma

    FDA Recall
    Terminated ·Abbott Laboratories Inc.·Product code CIX·March 10, 2010

    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·September 2, 2020

    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·September 2, 2020

    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·April 25, 2018

    Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·March 17, 2021

    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

    FDA Enforcement
    Class III ·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018

    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

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

    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

    FDA Enforcement
    Class III ·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018

    25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.

    FDA Enforcement
    Class II ·Terminated·IDS (Immunodiagnostic Systems Ltd.)·January 23, 2013

    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

    FDA Enforcement
    Class II ·Terminated·Diagnostic Hybrids Inc·September 9, 2015

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    FDA Enforcement
    Class II ·Terminated·DRG International, Inc.·April 13, 2022

    Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·December 14, 2016

    MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

    FDA Enforcement
    Class III ·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018

    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·December 19, 2018