Prosthesis, Breast, External, Used With Adhesive
General, Plastic Surgery · 21 CFR 878.3800
Recent MDR events
14 adverse event reports on file
- EO IMPL., Ø 3.3 / 3.5MM, SLA 5.0MMJan 4, 2024InjuryInstitut Straumann Ag0009613348-2024-002019
- EO IMPL., Ø 3.3 / 3.5MM, SLA 5.0MMJan 20, 2022InjuryInstitut Straumann Ag0009613348-2022-08432
- EO IMPL., Ø 3.3 / 3.5MM, SLA 5.0MMNov 8, 2021InjuryInstitut Straumann Ag0009613348-2021-86431
- EO IMPL., 3.3 / 5.5MM, SLA 2.5MMMar 8, 2021InjuryInstitut Straumann Ag0009613348-2021-15444
- BRAVA BRAMar 1, 2002OtherBrava, LlcMW1024232
- AMOENANov 3, 2000InjuryColoplast Corp.2125337-2000-00001
- AMOENAOct 24, 2000InjuryColoplastMW1020298
- JODEE BRAJul 30, 1998MalfunctionJodee Bra, Inc.MW1014272
- AMOENAJun 13, 1998InjuryColoplast Corp1046831-1998-00001
- NATURAL WEAR BREAST FORMSJan 24, 1997MalfunctionCamp International Inc.MW1010606
Event type breakdown
Registered firms
17 firms currently registered for this product code
Institut Straumann Ag
BASEL Basel-Stadt, CH
Allmay Bodywear (shenzhen) Co., Ltd
Shenzhen Guangdong, CN
Steris Schweiz Ag
Daniken Solothurn, CH
Natural Breast Co., Ltd.
Fukuoka-City, JP
Anita Dr. Helbig Gmbh (austria)
KUFSTEIN Tirol, AT
Allmay International Limited
Tsimshatsui, HK
Thuasne Deutschland Gmbh
Burgwedel Lower Saxony, DE
American Breast Care Lp
Marietta, GA, US
Steco-system-technik Gmbh & Co. Kg
HAMBURG, DE
Anita Canada Ltd.
Toronto Ontario, CA
Pink Perfect
Kfar Saba Central, IL
Nanning Sixtant Biotechnology Co., Ltd
Nanning Guangxi, CN
Anita Dr. Helbig Gmbh
BRANNENBURG Bavaria, DE
Amoena Usa Corporation
Kennesaw, GA, US
Delta Molding Llc
Woodland, CA, US
Straumann Villeret Sa
VILLERET Bern, CH
Amoena Medizin-orthopadie-technik Gmbh
RAUBLING, BAVARIA, DE
510(k) clearances
13 clearances for this product code
- Straumann USAApr 16, 1999
K990458 · STRAUMANN EXTRAORAL IMPLANT SYSTEM
- Maxol Limited L.C.May 26, 1995
K951324 · MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS
- Great Bay Medical Products, Inc.Jul 20, 1994
K933465 · COSMET
- Dekumed, Kunststofftechnik Degler GmbHDec 22, 1993
K932978 · CALSSIQUE OR MYSTIQUE
- Hemispheres Marketing Co. , Ltd.Dec 16, 1993
K932899 · CLASSIQUE
- Almost U., Inc.Dec 10, 1993
K933668 · ALMOST U, INC. BREAST PROSTHESIS
- Coloplast Corp.May 11, 1992
K921535 · SUOENA AFFINITY (TM) MODEL #802
- Coloplast Corp.Jan 14, 1992
K915382 · AMOENA AFFINITY MODEL #802