FDA 510(k) Applications for Medical Device Product Code "LWH"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K093557 | CLEARCOUNT MEDICAL SOLUTIONS | SMARTWAND-DTX | 12/18/2009 |
K073180 | CLEARCOUNT MEDICAL SOLUTIONS, INC. | SMARTSPONGE PLUS SYSTEM | 11/19/2007 |
K071355 | CLEARCOUNT MEDICAL SOLUTIONS, INC. | SMARTSPONGE SYSTEM | 05/24/2007 |
K121274 | GAUSS SURGICAL, INC. | PIXEL APP | 06/27/2012 |
K120473 | GAUSS SURGICAL, INC. | PIXEL APP | 04/09/2012 |
K100551 | HALDOR ADVANCED TECHNOLOGIES LTD | ORLOCATE SYSTEM MODEL ORL 100 | 08/12/2010 |
K982260 | MARKWELL INTL., INC. | MARKWELL GAUZE SPONGE | 08/12/1998 |
K061316 | MEDLINE INDUSTRIES, INC. | MEDLINE SURGICAL SPONGE SCANNER | 11/02/2006 |
K062642 | RF SURGICAL SYSTEMS, INC. | RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A | 11/02/2006 |
K972302 | SAGE PRODUCTS, INC. | POCKET COUNT OR SAFETCOUNT | 07/25/1997 |
K060076 | SURGICOUNT MEDICAL | SURGICOUNT SAFETY-SPONGE SYSTEM | 03/14/2006 |