3 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code LRO·August 15, 2007
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015