63 results
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14ms
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Sources: EU EUDAMED, US FDA
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
FDA Enforcement
Class II
·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·December 19, 2018
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
FDA Enforcement
Class II
·Completed·Abbott Diabetes Care, Inc.·January 24, 2024
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Enforcement
Class II
·Completed·Fresenius Medical Care Holdings, Inc.·November 18, 2020
Discovery NM/CT 670 Pro, model 5376204-70-54
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·December 19, 2018
Discovery NM/CT 670 ES, model 5376204-70-57
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·December 19, 2018
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 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
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
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
FDA Enforcement
Class I
·Completed·ResMed Ltd.·February 12, 2020
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
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
FDA Enforcement
Class II
·Completed·Murata Vios, Inc.·January 22, 2025
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Completed·ICU Medical, Inc.·October 10, 2018
VariCam
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
FDA Enforcement
Class II
·Completed·Withings Sas·August 22, 2018
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Enforcement
Class II
·Completed·SynCardia Systems LLC·November 1, 2023
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
FDA Enforcement
Class II
·Completed·C.R. Bard, Inc.·April 26, 2017
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
FDA Enforcement
Class II
·Completed·Appliedvr·July 5, 2023
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
FDA Enforcement
Class I
·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021