39 results
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6ms
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Sources: EU EUDAMED, US FDA
inLight Medical LED Pads used with Polychromatic light technology system
FDA Enforcement
Class III
·Terminated·Inlightened Partners LLC·June 30, 2021
PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.
FDA Enforcement
Class III
·Terminated·Polymer Technology Systems, Inc.·August 14, 2019
Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.
FDA Enforcement
Class III
·Terminated·Polymer Technology Systems, Inc.·August 14, 2019
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.
FDA Enforcement
Class III
·Terminated·Cytocell Ltd.·June 26, 2019
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
FDA Enforcement
Class III
·Terminated·Cytocell Ltd.·May 1, 2019
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
FDA Enforcement
Class III
·Terminated·Cytocell Ltd.·March 30, 2022
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
FDA Enforcement
Class III
·Terminated·Cytocell Ltd.·March 30, 2022
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·May 15, 2024
Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
FDA Enforcement
Class III
·Terminated·Bion Enterprises Ltd·June 12, 2013
Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
FDA Enforcement
Class III
·Terminated·Bion Enterprises Ltd·June 12, 2013