Panels › General, Plastic Surgery › Product code MDA · Class 1
Elastomer, Silicone, For Scar Management
Regulation 878.4025
0510(k)s in 12 months (81 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MDA
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio Med Sciences, Inc. | 7 | 0 |
| Biodermis Corp. | 4 | 0 |
| Implantech Associates, Inc. | 3 | 0 |
| Pmt Corp. | 3 | 0 |
| Silipos, Inc. | 3 | 0 |
| Advanced Bio-Technologies, Inc. | 2 | 0 |
| Allied Biomedical Corp. | 2 | 0 |
| Brennen Medical, Inc. | 2 | 0 |
| Capital Marketing Technologies, Inc. | 2 | 0 |
| Crown Delta Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 1997 | K970702 | SPECTRUM DESIGNS SPECTRAGEL Spectrum Designs, Inc. | MDA |
| Feb 12, 1997 | K964846 | IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING Implantech Associates, Inc. | MDA |
| Dec 5, 1996 | K963128 | NOVAGEL SILICONE GEL SHEETING Brennen Medical, Inc. | MDA |
| Sep 3, 1996 | K961410 | DURASIL (MODIFICATION) The S. F. Group, Inc. | MDA |
| Aug 22, 1996 | K962013 | MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT Mentor Corp. | MDA |
| Apr 2, 1996 | K960254 | SILGEL TOPICAL GEL SHEET Rofil Medical USA, Inc. | MDA |
| Feb 28, 1996 | K955664 | STERILIZED TRI BLOCK POLYMER GEL SHEET Silipos, Inc. | MDA |
| Nov 29, 1995 | K954413 | KELOCOTE Allied Biomedical Corp. | MDA |
| Nov 22, 1995 | K952612 | DURASIL The S. F. Group, Inc. | MDA |
| Sep 26, 1995 | K953420 | SILK*SKIN SCAR TREATMENT Silk*Skin Care Co. | MDA |
| Aug 7, 1995 | K952546 | SILON SILICONE TEXTILE COMPOSITE Bio Med Sciences, Inc. | MDA |
| Jul 13, 1995 | K946362 | SILON SILICONE FOAM SHEETING Bio Med Sciences, Inc. | MDA |
| Mar 3, 1995 | K945892 | SILON(R) SILICONE THERMOPLASTIC SHEETING Bio Med Sciences, Inc. | MDA |
| Nov 28, 1994 | K942339 | SKIN NEUVEAU SCAR TREATMENT Puritas Health Care, Inc. | MDA |
| Nov 10, 1994 | K942695 | TRI BLOCK POLUMER GEL SHEETING Silipos, Inc. | MDA |
| Aug 11, 1994 | K941197 | SILK*SKIN SCAR TREATMENT Puritas Health Care, Inc. | MDA |
| Jun 13, 1994 | K942156 | EPI-DERM SILICONE GEL SHEETING Biodermis Corp. | MDA |
| May 31, 1994 | K941125 | NOVAGEL SILICONE GEL SHEETING Brennen Medical, Inc. | MDA |
| May 12, 1994 | K933811 | MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST Pitt Enterprises (Silicone) , Ltd. | MDA |
| Apr 4, 1994 | K925583 | JOBSKIN CONTINUING CARE Jobst Institute, Inc. | MDA |
| Feb 10, 1994 | K935499 | PMT SILICONE SHEETING Pmt Corp. | MDA |
| Feb 3, 1994 | K935803 | CICA-CARE SILICONE GEL SHEET Smith & Nephew United, Inc. | MDA |
| Feb 3, 1994 | K934829 | HASKON MEDICAL GRADE SHEETING Haskon Intl., Inc. | MDA |
| Jan 7, 1994 | K932048 | SILICONE GEL SHEETING Silipos, Inc. | MDA |
| Jan 6, 1994 | K932214 | SILON SILICONE GEL SHEET Bio Med Sciences, Inc. | MDA |
| Sep 1, 1993 | K930409 | PMT(R) SILICONE GEL SHEETING MODEL 3505-1 Pmt Corp. | MDA |
| Jan 31, 1992 | K914701 | SIL-K Degania Silicone , Ltd., IL | MDA |
| Sep 30, 1991 | K913140 | SILICONE GEL SHEETING Cui Corp. | MDA |
| Sep 14, 1990 | K901991 | SILICONE ELASTOMER PUTTY Crown Delta Corp. | MDA |
| Sep 14, 1990 | K901990 | VINYL SILICONE ELASTOMER MATERIAL Crown Delta Corp. | MDA |
| Apr 17, 1985 | K840113 | SILICONE SPLINTING MATERIAL General Dental Products, Inc. | MDA |
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