8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
FDA Enforcement
Class II
·Terminated·Remel Inc·December 25, 2013
COACH¿ Self-Adhering Sports Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
COACH¿ Self-Adhering Sports Wrap (size: 3in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.
FDA Enforcement
Class II
·Completed·Alliance Tech Medical, Inc·December 25, 2019