30 results
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13ms
·
Sources: EU EUDAMED, US FDA
Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
FDA Recall
Terminated
·Stryker Howmedica Osteonics·Product code MEH·December 2, 2002
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
FDA Recall
Terminated
·Omnilife Science Inc.·Product code LZO·May 9, 2014
IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.
FDA Recall
Terminated
·Exalenz Bioscience Ltd Hamaayan 4 Modiin Israel·Product code MSQ·June 7, 2011
Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.
FDA Recall
Terminated
·Stardental Division·Product code EFA·December 1, 2006
Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic.
FDA Recall
Terminated
·Dade Behring Inc.·Product code DHA·April 3, 2006
Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
FDA Recall
Terminated
·DPC Cirrus·Product code DHA·October 29, 2004
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code DHA·November 11, 2015
Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.
FDA Recall
Terminated
·Dade Behring Inc.·Product code DHA·April 3, 2006
Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
FDA Recall
Terminated
·BioCheck Inc·Product code DHA·December 22, 2010
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.
FDA Recall
Terminated
·Kerr Corporation·Product code EBA·November 17, 2011
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 Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DHA·February 18, 2016
ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DHA·March 5, 2018
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
FDA Recall
Terminated
·Dental EZ Group Star Dental Division·Product code EFA·June 13, 2014
Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
FDA Recall
Terminated
·Nichols Institute Diagnostics·Product code DHA·August 31, 2005
Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
FDA Recall
Terminated
·Nichols Institute Diagnostics·Product code DHA·August 31, 2005
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
FDA Recall
Terminated
·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code DHA·November 21, 2018
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
FDA Recall
Terminated
·Dental EZ Stardental Division·Product code EFA·August 11, 2010
Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
FDA Recall
Terminated
·BioCheck Inc·Product code DHA·December 22, 2010
Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code DHA·November 11, 2015
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Recall
Terminated
·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018