FDA 510(k) Applications Submitted by Barbara L Smith

FDA 510(k) Number Submission Date Device Name Applicant
K010103 01/12/2001 SURSHIELD WINGED INFUSION SET TERUMO MEDICAL CORP.
K040531 03/01/2004 TERUMO SURGUARD2 SAFETY NEEDLE TERUMO MEDICAL CORP.
K031266 04/21/2003 SURSHIELD SAFETY WINGED INFUSION SET TERUMO CORP.
K031453 05/07/2003 TERUMO SURGUARD 2 SAFETY NEEDLE TERUMO MEDICAL CORP.
K051865 07/11/2005 TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR TERUMO MEDICAL CORP.
K052034 07/28/2005 TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO MEDICAL CORP.
K012646 08/13/2001 TERUMO 30 GAUGE HYPODERMIC NEEDLE TERUMO MEDICAL CORP.
K052561 09/19/2005 TERUMO MICRO TAPERED PEN NEEDLE KOFU FACTORY OF TERUMO CORP.
K013164 09/21/2001 SURSHIELD SAFETY WINGED BLOOD COLLECTION SET TERUMO MEDICAL CORP.
K003571 11/20/2000 SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE TERUMO MEDICAL CORP.
K024249 12/23/2002 TERUMO SURGUARD SAFETY SYRINGE TERUMO MEDICAL CORP.
K070644 03/08/2007 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS W. L. GORE & ASSOCIATES, INC.
K131658 06/06/2013 GORE SEAMGUARD REINFORCEMENT W. L. GORE & ASSOCIATES, INC.
K222919 09/26/2022 GORE« ENFORM Biomaterial W. L. Gore and Associates, Inc.
K173333 10/23/2017 GORE ENFORM Biomaterial W.L. Gore & Associates, Inc.
K083266 11/05/2008 GORE BIO-A FISTULA PLUG W.L. GORE & ASSOCIATES,INC
K163217 11/16/2016 GORE BIO-A Tissue Reinforcement W. L. GORE & ASSOCIATES, INC.
K132397 08/01/2013 GORE BIO-A WOUND MATRIX W. L. GORE & ASSOCIATES, INC.
K150551 03/04/2015 GORE SEAMGUARD Reinforcement W. L. GORE & ASSOCIATES, INC.
K170740 03/10/2017 GORE VIABIL Short Wire Biliary Endoprosthesis W.L. Gore & Associates, Inc.
K191773 07/02/2019 GORE BIO-A Tissue Reinforcement W.L. Gore & Associates, Inc.
K152609 09/14/2015 GORE SYNECOR Biomaterial W.L GORE & ASSOCIATES, INC.


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