105 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·July 31, 2013
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
FDA Recall
Terminated
·Cook Inc.·Product code FFK·January 31, 2018
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 9, 2018
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
CDI Blood Parameter Monitoring System 500, 500AVHCT. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
CDI Blood Parameter Monitoring System 500, 500A. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
CDI Blood Parameter Monitoring System 500, 500V. Intended for use during cardiopulmonary bypass procedures.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·December 17, 2013
Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·December 17, 2013
SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.
FDA Enforcement
Class II
·Terminated·SCC Soft Computer·May 21, 2014
SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
FDA Enforcement
Class II
·Terminated·SCC Soft Computer·August 15, 2012
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
FDA Enforcement
Class II
·Terminated·SCC Soft Computer·February 18, 2015
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
FDA Enforcement
Class II
·Terminated·SCC Soft Computer·February 11, 2015
Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
FDA Enforcement
Class II
·Terminated·SSC- Surgical Specialties Corporation·June 29, 2016
SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).
FDA Recall
Terminated
·SCC Soft Computer·Product code LNX·June 23, 2010
Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
FDA Recall
Terminated
·SCC Soft Computer·Product code JQP·August 8, 2011
SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
FDA Recall
Terminated
·SCC Soft Computer·Product code JQP·October 17, 2011