20 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·March 15, 2023
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·March 15, 2023
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·May 7, 2025
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·May 7, 2025
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·September 6, 2023
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·September 6, 2023
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·September 6, 2023
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·November 13, 2024
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·May 6, 2026
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 1, 2025
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·December 27, 2023
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·August 13, 2025
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·July 20, 2022