11 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·October 23, 2024
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·October 12, 2016
Amerigel Wound Dressing 1 oz. tube
FDA Enforcement
Class II
·Terminated·Kova Laboratories, Inc.·July 16, 2014
Amerigel Wound Dressing 55 gallons/drum
FDA Enforcement
Class II
·Terminated·Kova Laboratories, Inc.·July 16, 2014
4205 Journey Rolling Walker Product Usage: used to assist people in walking
FDA Enforcement
Class II
·Terminated·Nova Ortho-Med Inc·November 2, 2016
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
FDA Enforcement
Class II
·Ongoing·Nova Ortho-Med Inc·December 30, 2020