17 results
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7ms
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Sources: EU EUDAMED, US FDA
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·June 28, 2017
Merge PACS software. The firm name on the label is Merge Healthcare.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·March 15, 2017
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 10, 2014
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
FDA Enforcement
Class II
·Terminated·DT MedTech, LLC·November 14, 2018
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
FDA Enforcement
Class II
·Terminated·DT MedTech, LLC·November 14, 2018