26 results
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6ms
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Sources: EU EUDAMED, US FDA
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014
SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems Usa Com·July 5, 2017
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Ansh Labs, LLC·January 20, 2021
Swan-Ganz Pacing Catheter, Models: D200F7;
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·August 22, 2012
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
FDA Enforcement
Class II
·Ongoing·Edwards Lifesciences, LLC·April 19, 2023
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
FDA Enforcement
Class II
·Ongoing·Edwards Lifesciences, LLC·April 19, 2023