37 results
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19ms
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Sources: EU EUDAMED, US FDA
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O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
FDA Enforcement
Class II
·Terminated·Orchestrate Orthodontic Technologies, Inc.·December 15, 2021
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
FDA Recall
Terminated
·Orchestrate Orthodontic Technologies, Inc.·Product code PNN·November 11, 2021
Zoll M Series Automated Defibrillator (AED)
FDA Recall
Terminated
·Zoll Medical Corporation·Product code MKT·August 2, 2004
cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping of sample tubes, liquid level detection (optional) and sample quality detection (optional), as well as recapping of sample tubes (optional).
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code MKT·July 15, 2016
biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers)
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code MKT·June 13, 2007
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or as a diagnostic test to confirm the presence of HBV infection.
FDA Recall
Terminated
·Abbott Molecular·Product code MKT·December 20, 2010
COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code MKT·December 28, 2010
ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·February 5, 2020
BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·February 5, 2020
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 Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 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 Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
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 Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
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 Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
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 Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
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 Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014