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Rochester Medical Corp

22 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or 71201 recall (Z-1906-2010)Rochester Medical Corp2010-06-25
FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, R recall (Z-1907-2010)Rochester Medical Corp2010-06-25
FemSoft Insert, Female Urethral Insert, Size 2 Standard, 3.5 cm Length, Sterile (R), Rx On recall (Z-1908-2010)Rochester Medical Corp2010-06-25
FemSoft Insert, Female Urethral Insert, Size 3 Standard, 3.5 cm Length, Sterile (R), Rx On recall (Z-1909-2010)Rochester Medical Corp2010-06-25
FemSoft Insert, Female Urethral Insert, Size 1 Long, 4.5 cm Length, Sterile (R), Rx Only, recall (Z-1910-2010)Rochester Medical Corp2010-06-25
FemSoft Insert, Female Urethral Insert, Size 2 Long, 4.5 cm Length, Sterile (R), Rx Only, recall (Z-1911-2010)Rochester Medical Corp2010-06-25
FemSoft Insert, Female Urethral Insert, Size 3 Long, 4.5 cm Length, Sterile (R), Rx Only, recall (Z-1912-2010)Rochester Medical Corp2010-06-25
FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, R recall (Z-1913-2010)Rochester Medical Corp2010-06-25
Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF # 52306 Ro recall (Z-1074-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308 Roch recall (Z-1075-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Pediatric Length REF 52310 Roc recall (Z-1076-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606 R recall (Z-1077-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Male Length REF 53310 Rocheste recall (Z-1078-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF 52608 R recall (Z-1079-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610 recall (Z-1080-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612 Roche recall (Z-1081-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF 53614 Roche recall (Z-1082-2009)Rochester Medical Corp2009-03-16
Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616 Roche recall (Z-1083-2009)Rochester Medical Corp2009-03-16
HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs recall (Z-1084-2009)Rochester Medical Corp2009-03-16
HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs REF#63614 recall (Z-1085-2009)Rochester Medical Corp2009-03-16
HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612 Rochester Me recall (Z-1086-2009)Rochester Medical Corp2009-03-16
HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614 Rochester Med recall (Z-1087-2009)Rochester Medical Corp2009-03-16

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