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Apogee Medical, Inc

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating recall (Z-2133-2011)Apogee Medical, Inc2011-05-03
Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The dev recall (Z-2390-2008)Apogee Medical, Inc2008-09-21
Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The dev recall (Z-2391-2008)Apogee Medical, Inc2008-09-21
Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The de recall (Z-2392-2008)Apogee Medical, Inc2008-09-21
Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Lat recall (Z-2393-2008)Apogee Medical, Inc2008-09-21
Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Late recall (Z-2394-2008)Apogee Medical, Inc2008-09-21

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Every clearance here is in the API, with alerts when new ones post.