16 results
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26ms
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Sources: EU EUDAMED, US FDA
REAGENTS SERUM CREATINE USING TECHICON
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750002061·VITROS Immunodiagnostic Products NT proBNP Reag...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668118351·Anis NdlHldr, Str, W/O Lock, X-Delicate
ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APPRAISE URINE MICROALBUMIN COLLECTION KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
4.5MM NARROW LCP® PLATE 11 HOLES/206MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·August 12, 2015
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
FDA Enforcement
Class II
·Terminated·ORTHO-CLINICAL DIAGNOSTICS·April 19, 2017
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
FDA Recall
Terminated
·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code NBC·March 7, 2017
Allura Xper FD20; Model Number: 722012;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
FDA Enforcement
Class II
·Ongoing·ORTHO-CLINICAL DIAGNOSTICS·January 9, 2019
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.
FDA Recall
Open, Classified
·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code NBC·November 1, 2018
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022