| K880329 | FACTOR II PROSTHETIC SILICONE ELASTOMER | FACTOR, II, INC. |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | ROSEBURG SA |
| K864785 | AMOENA BREAST FORMS | COLOPLAST CORP. |
| K864786 | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT | COLOPLAST CORP. |
| K853822 | AMOENA BREAST FORMS | COLOPLAST CORP. |
| K842765 | SILIMED BREAST FORM | SIL-MED CORP. |
| K841559 | CONFORMA | BEIERSDORF, INC. |
| K841171 | TRILICON BREASE PROSTHESIS DIFFERENT | BAURS KREY ASSOC., INC. |
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | DELAWARE PROSTHETICS, INC. |
| K832152 | PDM SILOXANE PROSTHETIC EAR | DELAWARE PROSTHETICS, INC. |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | DELAWARE PROSTHETICS, INC. |
| K831831 | TRULIFE SILICONE BREAST FORM | MEDEERING, LTD. |
| K813416 | EXTERNAL BREAST PROSTHESIS | SURGICAL APPLIANCE INDUSTRIES, INC. |
| K792372 | IPOS BREAST PROSTHESIS | IPOS KG |