42 results
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9ms
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Sources: EU EUDAMED, US FDA
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA Enforcement
Class II
·Ongoing·On-X Life Technologies, Inc.·May 20, 2026
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
FDA Enforcement
Class II
·Terminated·On-X Life Technologies, Inc.·February 1, 2017
ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
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
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
Dimension Assays: Triglycerides (TGL)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Advia Chemistry Assay: Lactate
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Assays: Uric Acid (URCA)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Vista Assays: Triglycerides (TRIG)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Assays: ENZYMATIC CREATININE
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Advia Chemistry Assay: LDL Cholesterol, Direct
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Vista Assays: Uric Acid (URCA)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Vista Assays: Enzymatic Creatine (ECRE)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 17, 2020