11 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
BD Microtainer SST- Amber Part/Catalog Number: 365978
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·May 29, 2024
BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·December 4, 2019
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 29, 2020
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·September 18, 2024
Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320
FDA Enforcement
Class II
·Terminated·Sentinel CH SpA·October 2, 2019
STA SYSTEM CONROL N + P (ref. 00678)
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·January 1, 2020