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 |
|---|---|---|---|
| Sep 29, 2011 | K112131 | NEODYNE DRESSING Neodyne Biosciences, Inc. | MDA |
| Sep 22, 2011 | K111733 | CORELEADER SCAR-DIMMER Coreleader Biotech Co., Ltd., TW | MDA |
| Jan 26, 2009 | K083718 | BEAU RX SCAR CARE GEL Beau RX Solutions, LLC | MDA |
| Apr 14, 2006 | K053481 | KELO-COTE SPRAY Advanced Bio-Technologies, Inc. | MDA |
| Oct 17, 2005 | K041704 | NEWGEL AND NEWGEL PLUS E Newmedical Technology, Inc. | MDA |
| Aug 12, 2004 | K040307 | HANSON SCAR ADE Hanson Medical, Inc. | MDA |
| Jun 18, 2003 | K024057 | CURAD SCAR THERAPY Beiersdorf, Inc. | MDA |
| Mar 17, 2003 | K024160 | NEOSPORIN SCAR SOLUTION Warner-Lambert Co. | MDA |
| Jan 23, 2003 | K023678 | DIMISIL SCAR GEL Aesthetic and Reconstructive Technologies, Inc. | MDA |
| Oct 16, 2002 | K023136 | OLEEVA FABRIC Bio Med Sciences, Inc. | MDA |
| Feb 14, 2002 | K014036 | MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. Medtrade Products , Ltd., GB | MDA |
| Feb 7, 2002 | K013732 | GELZONE Implantech Associates, Inc. | MDA |
| Oct 24, 2001 | K012419 | CONFORM SHEETING, MODEL IGEL Implantech Associates, Inc. | MDA |
| May 30, 2001 | K010675 | ENSIL FABRIC Gottfried Medical, Inc. | MDA |
| Apr 25, 2001 | K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING Advanced Medical Solutions, Ltd., GB | MDA |
| Mar 19, 2001 | K003979 | MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD Medtrade Products , Ltd., GB | MDA |
| Jan 29, 2001 | K003948 | EPI-DERM SILICONE GEL SHEETING Biodermis Corp. | MDA |
| Jan 5, 2001 | K002488 | KELO-COTE TOPICAL GEL Advanced Bio-Technologies, Inc., GB | MDA |
| Aug 31, 2000 | K002109 | OLEEVA FOAM Bio Med Sciences, Inc. | MDA |
| Jul 25, 2000 | K001608 | BLAINE SCARCARE PATCH Blaine Labs, Inc. | MDA |
| Oct 26, 1999 | K992522 | SPECTRUM DESIGNS SPECTRAGEL Spectrum Designs, Inc. | MDA |
| Oct 25, 1999 | K991970 | SCAREASE SHEETS & SCAREASE GEL Pillar Surgical | MDA |
| Aug 20, 1999 | K991312 | SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING Library Medical, Inc. | MDA |
| Aug 13, 1999 | K990651 | SKIN 2 FORTE SILICONE SHEETING United Hospital Technologies, Inc. | MDA |
| Aug 5, 1999 | K984029 | SILGEL STC-S Nagor , Ltd., VG | MDA |
| Jul 30, 1999 | K992146 | SCARAID SILICONE GEL SHEETING Biodermis Corp. | MDA |
| Jul 30, 1999 | K991968 | CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. Smith & Nephew, Inc. | MDA |
| Jul 20, 1999 | K991957 | CICACARE MANAGEMENT FOR SCARS Smith & Nephew, Inc. | MDA |
| Jun 21, 1999 | K991478 | TENDER TOUCH SILICONE GEL PADS Capital Marketing Technologies, Inc. | MDA |
| Jun 11, 1999 | K991630 | ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET Advanced Medical Solutions Group Plc, GB | MDA |
| Jun 9, 1999 | K991604 | EPI-FOAM SILICONE SHEETING Biodermis Corp. | MDA |
| Jun 1, 1999 | K981353 | AVOGEL Avocet Polymer Technologies, Inc. | MDA |
| Apr 14, 1999 | K984213 | NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS Capital Marketing Technologies, Inc. | MDA |
| Feb 12, 1999 | K984115 | SCAREASE & SCAREASE ADHESIVE GEL Scarease, Inc. | MDA |
| Aug 6, 1998 | K982036 | SILON SCAR STRIPS Bio Med Sciences, Inc. | MDA |
| Aug 5, 1998 | K982051 | KELOCATE SHEETING Allied Biomedical Corp. | MDA |
| Jun 25, 1998 | K981902 | SPENCO SILICONE GEL SHEET Spenco Medical Corp. | MDA |
| Jun 10, 1998 | K981387 | EVANESCE SCAR MANAGEMENT SYSTEM Medical Scientific, Inc. | MDA |
| May 20, 1998 | K980563 | SKAR-KARE SHEET Life Medical Sciences, Inc. | MDA |
| Apr 3, 1998 | K974380 | REJUVENESS Rejuveness Pharamceuticals, Inc. | MDA |
| Mar 30, 1998 | K974172 | SILGEL TOPICAL GEL SHEET Nagor , Ltd., VG | MDA |
| Mar 27, 1998 | K974143 | KMC NEWSKIN Kmc Intl. Co. | MDA |
| Mar 5, 1998 | K974354 | MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE Sca Molnlycke | MDA |
| Nov 19, 1997 | K973271 | SKAR-KARE Target Health, Inc. | MDA |
| Oct 21, 1997 | K973572 | KELOCOTE SCAR GEL AND KELOCOTE LASER GEL Hanson Medical, Inc. | MDA |
| Oct 1, 1997 | K972597 | PMT NEW BEGINNINGS GELSHAPES & AMEND Pmt Corp. | MDA |
| Jul 29, 1997 | K971916 | MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL Medical Z, S.A. | MDA |
| Jul 29, 1997 | K971009 | SCAR CARE Target Health, Inc. | MDA |
| Jun 24, 1997 | K971482 | DEGANIA SILICONE SIL-K Degania Silicone , Ltd., IL | MDA |
| Jun 10, 1997 | K971468 | SCAR HEAL Specialty Systems, Inc. | MDA |
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