11 results
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15ms
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Sources: EU EUDAMED, US FDA
Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·May 8, 2019
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·May 8, 2019
Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·May 8, 2019
SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·May 8, 2019
JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
FDA Enforcement
Class II
·Terminated·Carefusion 2200 Inc·April 25, 2018
JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
FDA Enforcement
Class II
·Terminated·Carefusion 2200 Inc·April 25, 2018
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
FDA Enforcement
Class II
·Ongoing·Btt Health Gmbh·September 25, 2024
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.
FDA Enforcement
Class II
·Terminated·BTE Technologies, Inc.·July 15, 2015
cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 2, 2015
cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 2, 2015
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 1, 2017