32 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Synapse PACS - Version 7.1.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.2.200
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.2.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.3.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.1.000US
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 6, 2019
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
FDA Enforcement
Class II
·Terminated·DePuy Spine, Inc.·June 3, 2015
Synapse PACS Software Versions 5.1 and higher
FDA Enforcement
Class II
·Ongoing·Fujifilm Medical Systems U.S.A., Inc.·January 27, 2021
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·February 28, 2024
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·February 28, 2024
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
FDA Enforcement
Class II
·Terminated·Simpleware Product Group, SYNOPSYS NORTHERN EUROPE·August 18, 2021
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
FDA Enforcement
Class II
·Terminated·Simpleware Product Group, SYNOPSYS NORTHERN EUROPE·August 18, 2021