13 results
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19ms
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Sources: EU EUDAMED, US FDA
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VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 14, 2018
VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 14, 2018
VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 14, 2018
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 14, 2018
VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 14, 2018
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 29, 2020
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining the presence of barbiturates (BARB) and its metabolites in urine.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·May 6, 2020
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Enforcement
Class II
·Terminated·B Braun Medical, Inc.·September 18, 2013
Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B; g) BIOPSY TRAY FOAKS, REF DYNJ63575A; h) CUSTOM SOFT TISSUE PACK, REF DYNJ66347A; i) KWIK PACK, REF DYNJ67926B; j) ESI TRAY, REF DYNJ68261B; k) LARGE BIOPSY PACK NTX, REF DYNJ68393A; l) LOOP KIT, REF DYNJ84129
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024
Hintermann Series Talar Implant, Left, Size 2 REF 302112
FDA Enforcement
Class II
·Ongoing·DT MedTech, LLC·June 17, 2026
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
FDA Enforcement
Class II
·Terminated·DT MedTech, LLC·November 14, 2018
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
FDA Enforcement
Class II
·Terminated·DT MedTech, LLC·November 14, 2018