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ConvaTec

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring recall (Z-1431-2010)ConvaTec2010-04-22
Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M. recall (Z-1142-2010)ConvaTec2010-03-16
ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, ( recall (Z-1814-2009)ConvaTec2009-09-29
Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; recall (Z-2043-2009)ConvaTec2009-09-09
Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System; Sterile, recall (Z-2044-2009)ConvaTec2009-09-09
Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pre recall (Z-2045-2009)ConvaTec2009-09-09
Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter recall (Z-0618-2009)ConvaTec2008-12-30
GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UP recall (Z-1314-2008)ConvaTec2008-07-02
Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouc recall (Z-1179-2008)ConvaTec2008-05-07
ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm ( recall (Z-1531-06)ConvaTec2006-09-27
ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm ( recall (Z-1532-06)ConvaTec2006-09-27
Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. recall (Z-1432-06)ConvaTec2006-08-24

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