122 results
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20ms
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Sources: EU EUDAMED, US FDA
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
FDA Enforcement
Class II
·Completed·Withings Sas·August 22, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·June 18, 2025
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·June 18, 2025
Azurion systems with software release R2.0.x
FDA Enforcement
Class II
·Completed·Philips Healthcare·March 30, 2022
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
FDA Enforcement
Class II
·Completed·Percussionaire Corporation·November 15, 2023
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
FDA Enforcement
Class II
·Completed·Baxter Healthcare Corp.·March 25, 2015
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018