Panels › General, Plastic Surgery › Product code GBI · Class 1
Material, External Aesthetic Restoration, Used With Adhesive
Regulation 878.3800
0510(k)s in 12 months (17 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Coloplast Corp. | 3 | 0 |
| Delaware Prosthetics, Inc. | 3 | 0 |
| Allan V. Marse | 1 | 0 |
| Baurs Krey Assoc., Inc. | 1 | 0 |
| Beiersdorf, Inc. | 1 | 0 |
| Factor, Ii, Inc. | 1 | 0 |
| Ipos KG | 1 | 0 |
| Medeering, Ltd. | 1 | 0 |
| Pacific Prosthetics, Inc. | 1 | 0 |
| Roseburg SA | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 1988 | K880329 | FACTOR II PROSTHETIC SILICONE ELASTOMER Factor, Ii, Inc. | GBI |
| Oct 29, 1987 | K874279 | AHH NATURAL BREAST FORM Pacific Prosthetics, Inc. | GBI |
| Jul 21, 1987 | K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY Roseburg SA | GBI |
| Jan 8, 1987 | K864786 | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT Coloplast Corp. | GBI |
| Jan 8, 1987 | K864785 | AMOENA BREAST FORMS Coloplast Corp. | GBI |
| Sep 30, 1985 | K853822 | AMOENA BREAST FORMS Coloplast Corp. | GBI |
| Jun 4, 1985 | K851668 | PROSTHESIS OR SURGICAL PADS Virginia Hall, Inc. | GBI |
| Aug 17, 1984 | K842765 | SILIMED BREAST FORM Sil-Med Corp. | GBI |
| Jul 17, 1984 | K841559 | CONFORMA Beiersdorf, Inc. | GBI |
| Apr 25, 1984 | K841171 | TRILICON BREASE PROSTHESIS DIFFERENT Baurs Krey Assoc., Inc. | GBI |
| Dec 19, 1983 | K832151 | PDM SILOXANE PROSTHETIC ORBIT Delaware Prosthetics, Inc. | GBI |
| Dec 9, 1983 | K832153 | PDM SILOXANE PROSTHETIC NOSE Delaware Prosthetics, Inc. | GBI |
| Dec 9, 1983 | K832152 | PDM SILOXANE PROSTHETIC EAR Delaware Prosthetics, Inc. | GBI |
| Jun 30, 1983 | K831831 | TRULIFE SILICONE BREAST FORM Medeering, Ltd. | GBI |
| Jan 18, 1982 | K813416 | EXTERNAL BREAST PROSTHESIS Surgical Appliance Industries, Inc. | GBI |
| Dec 19, 1979 | K792372 | IPOS BREAST PROSTHESIS Ipos KG | GBI |
| Apr 8, 1977 | K770359 | IMPLANTING OF POLYACRYLIC FIBERS Allan V. Marse | GBI |
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