Company ยท US
Ssl Americas, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2008. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 19, 2008 | K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM Ssl Americas, Inc. | MOL |
| May 7, 2008 | K072236 | DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT Ssl Americas | NUC |
| Apr 1, 2008 | K071626 | DUREX PLAY SOFT & SENSUAL LUBRICANT Ssl Americas | NUC |
| Mar 10, 2008 | K063385 | DUREX PLAY MASSAGE GEL LUBRICANT Ssl Americas, Inc. | NUC |
| Jun 8, 2006 | K060098 | DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS Ssl Americas, Inc. | NUC |
| Jan 27, 2006 | K052959 | DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS Ssl Americas | HIS |
| Apr 8, 2005 | K042958 | DUREX PLAY TINGLING LUBRICANT Ssl Americas, Inc. | NUC |
| Apr 5, 2005 | K042470 | DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM Ssl Americas, Inc. | HIS |
| Feb 23, 2005 | K042563 | DUREX PLAY WARMER LUBRICANT Ssl Americas, Inc. | KMJ |
| Feb 17, 2005 | K042957 | DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT Ssl Americas | HIS |
| Apr 27, 2004 | K040185 | DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM Ssl Americas | HIS |
| Mar 29, 2004 | K032227 | DUREX FLAVORED LATEX CONDOM Ssl Americas, Inc. | HIS |
| Mar 11, 2004 | K040353 | FLIGHT SOCK Ssl Americas, Inc. | DWL |
| Jan 16, 2004 | K032124 | DUREX PLAY LUBRICANT Ssl Americas, Inc. | HIS |
| Mar 29, 2002 | K020659 | DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT Ssl Americas, Inc. | HIS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2002 | SSL Americas Inc. Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, Terminated |
KGO | K000421 |