Panels › General Hospital › Product code LWH · Class 1
Counter, Sponge, Surgical
Regulation 880.2740
0510(k)s in 12 months (15 all time)
1recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in LWH
| Company | 510(k)s | Recalls |
|---|---|---|
| Clearcount Medical Solutions | 3 | 0 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 3 |
| Devon Industries, Inc. | 2 | 0 |
| Gauss Surgical, Inc., | 2 | 0 |
| Gorsk, Inc. | 1 | 0 |
| Haldor Advanced Technologies, Ltd. | 1 | 0 |
| Markwell Intl., Inc. | 1 | 0 |
| Medline Industries, Inc. | 1 | 0 |
| Michael Fischer Assoc. | 1 | 0 |
| Rf Surgical Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 27, 2012 | K121274 | PIXEL APP Gauss Surgical, Inc., | LWH |
| Apr 9, 2012 | K120473 | PIXEL APP Gauss Surgical, Inc., | LWH |
| Aug 12, 2010 | K100551 | ORLOCATE SYSTEM MODEL ORL 100 Haldor Advanced Technologies, Ltd., IL | LWH |
| Dec 18, 2009 | K093557 | SMARTWAND-DTX Clearcount Medical Solutions | LWH |
| Nov 19, 2007 | K073180 | SMARTSPONGE PLUS SYSTEM Clearcount Medical Solutions, Inc. | LWH |
| May 24, 2007 | K071355 | SMARTSPONGE SYSTEM Clearcount Medical Solutions, Inc. | LWH |
| Nov 2, 2006 | K062642 | RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A Rf Surgical Systems, Inc. | LWH |
| Nov 2, 2006 | K061316 | MEDLINE SURGICAL SPONGE SCANNER Medline Industries, Inc. | LWH |
| Mar 14, 2006 | K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM Surgicount Medical | LWH |
| Aug 12, 1998 | K982260 | MARKWELL GAUZE SPONGE Markwell Intl., Inc. | LWH |
| Jul 25, 1997 | K972302 | POCKET COUNT OR SAFETCOUNT Sage Products, Inc. | LWH |
| Jan 12, 1995 | K945144 | SPONGE COUNT Michael Fischer Assoc. | LWH |
| Aug 26, 1991 | K912824 | DEVON SPONGE COUNTER BAGS Devon Industries, Inc. | LWH |
| Oct 23, 1987 | K873555 | GORSK SPONGE CONTAINMENT SYSTEM Gorsk, Inc. | LWH |
| Apr 4, 1979 | K790538 | SPONGE COUNTER Devon Industries, Inc. | LWH |
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