Elastomer, Silicone, For Scar Management
General, Plastic Surgery · 21 CFR 878.4025
Recent MDR events
51 adverse event reports on file
- EPIDERM SILICONE GEL SCAR STRIPSJul 14, 2026MalfunctionBiodermis Llc1000135565-2026-02620
- 12 CM EMBRACE DRESSINGApr 1, 2026MalfunctionNeodyne Biosciences, Inc.MW5186276
- 16 CM EMBRACE DRESSINGApr 1, 2026MalfunctionNeodyne Biosciences, Inc.MW5186277
- EMBRACE DRESSINGApr 1, 2026MalfunctionNeodyne Biosciences, Inc.MW5186278
- SCARAWAY SILICONE CLEAR SCAR SHEETSAug 15, 2025InjuryBio Med Sciences, Inc.3019867040-2025-00001
- SCARAWAY SILICONE CLEAR SCAR SHEETJul 17, 2025InjuryAlliance Pharma, IncMW5172877
- SCARAWAY SILICONE SHEETSJan 2, 2025InjuryAlliance Pharma Inc.MW5164100
- EMBRACE SILICONE SCAR TREATMENTNov 29, 2023InjuryNeodyne Biosciences, Inc.MW5148580
- SCAR SILICONE GEL SHEETNov 29, 2023InjuryAreza Medical/advanced Medical Associates, Llc.MW5148585
- SCARAWAY SILICONE SCAR GELOct 5, 2023InjuryAlliance Pharma Inc.3019867040-2023-00003
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
213 firms currently registered for this product code
Anhui Ares Medical Technology Co.,ltd.
Tianchang Anhui, CN
Ortho Pauher Ind. Com. E Dist. Ltda
Recife Pernambuco, BR
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Nantong City Yojo Medical Products Co., Ltd.
Haimen Jiangsu, CN
Silipos Holding Llc
NIAGARA FALLS, NY, US
Toc Logistics / Sol-millenium Canada, Inc.
Balzac Alberta, CA
Shanghai Dynamic Medical Supplies Co., Ltd.
SHANGHAI, CN
Boston Medical Products, Inc.
Shrewsbury, MA, US
Biodermis Llc
Henderson, NV, US
Pharmaplast S.a.e.
ALEXANDRIA Al Iskandariyah, EG
Implantech Associates, Inc.
Ventura, CA, US
Molnlycke Health Care Ab
Molndal Vastra Gotaland, SE
Jiangsu Hongsheng Bioengineering Co., Ltd.
Nantong Jiangsu, CN
Trademark Cosmetics Inc. Dba Dmi Solutions
Riverside, CA, US
Coreleader Biotech Co., Ltd
New Taipei City, TW
Newmedical Technology, Inc.
NORTHBROOK, IL, US
Jiangsu Newvalue Medical Products Co., Ltd.
Taizhou Jiangsu, CN
Ningbo Hysent Medical Technology Co., Ltd
Ningbo Zhejiang, CN
Shanghai Chengsheng International Trading Co.,ltd
Shanghai, CN
Gravitiq Llc
New York, NY, US
Jiangsu Senwo Medical Technology Co., Ltd.
Nantong Jiangsu, CN
Ningbo Tianbo First Aid Product Co., Ltd.
Ningbo Zhejiang, CN
510(k) clearances
81 clearances for this product code
- Neodyne Biosciences, Inc.Sep 29, 2011
K112131 · NEODYNE DRESSING
- Coreleader Biotech Co., Ltd.Sep 22, 2011
K111733 · CORELEADER SCAR-DIMMER
- Beau RX Solutions, LLCJan 26, 2009
K083718 · BEAU RX SCAR CARE GEL
- Advanced Bio-Technologies, Inc.Apr 14, 2006
K053481 · KELO-COTE SPRAY
- Newmedical Technology, Inc.Oct 17, 2005
K041704 · NEWGEL AND NEWGEL PLUS E
- Hanson Medical, Inc.Aug 12, 2004
K040307 · HANSON SCAR ADE
- Beiersdorf, Inc.Jun 18, 2003
K024057 · CURAD SCAR THERAPY
- Warner-Lambert Co.Mar 17, 2003
K024160 · NEOSPORIN SCAR SOLUTION