20 results
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15ms
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Sources: EU EUDAMED, US FDA
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.
FDA Enforcement
Class III
·Ongoing·Trackx Technology Inc·November 6, 2024
BiomarC EX Fiducial Marker System, Catalog Number 040165
FDA Enforcement
Class III
·Ongoing·Carbon Medical Technologies, Inc.·September 25, 2024
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
FDA Enforcement
Class III
·Ongoing·Helena Laboratories, Corp.·December 4, 2019
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
FDA Enforcement
Class III
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Ingenia Ambition X, Model No. 782109
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Achieva 1.5T Conversion, Model No. 781283
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Intera 1.5T, Model No. 781195
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Achieva 3.0T, Model No. 781177
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Apo B Reagent, REF: OSR6143
FDA Enforcement
Class III
·Ongoing·Beckman Coulter Ireland, Inc.·June 4, 2025
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·July 5, 2023
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
FDA Enforcement
Class III
·Ongoing·Randox Laboratories Ltd.·July 5, 2023
SmartPath to dStream for 1.5T, Model No. 781260, 782112
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
AcoSound. Model Number: LW12-BTE-M
FDA Enforcement
Class III
·Ongoing·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.·June 25, 2025
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.
FDA Enforcement
Class III
·Ongoing·Baxter Healthcare Corporation·October 5, 2022
Achieva 1.5T, Model No. 781178, 781196, 781296
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
FDA Enforcement
Class III
·Ongoing·Beckman Coulter, Inc.·October 23, 2024
Battery Charging Station; Model: 0998-00-0802;
FDA Enforcement
Class III
·Ongoing·Datascope Corp.·March 25, 2026
Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)
FDA Enforcement
Class III
·Ongoing·Helena Laboratories, Corp.·December 4, 2019
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
FDA Enforcement
Class III
·Ongoing·R & D Systems, Inc.·July 27, 2022
VenaSeal Closure System
FDA Enforcement
Class III
·Ongoing·Medtronic Inc.·May 19, 2021