33 results
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28ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019
Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class II
·Terminated·Clinical Diagnostic Solutions·April 16, 2014
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 9, 2018
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 3, 2019
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Enforcement
Class II
·Terminated·Clinical Diagnostic Solutions, Inc.·February 12, 2020
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 9, 2018
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 9, 2018
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 16, 2024
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 24, 2018
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
FDA Enforcement
Class II
·Terminated·Alfa Wassermann, Inc.·February 6, 2013
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019