Panels › General, Plastic Surgery › Product code KCZ · Class 1
Prosthesis, Breast, External, Used With Adhesive
Regulation 878.3800
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in KCZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Coloplast Corp. | 3 | 0 |
| Coloplast A/S | 2 | 0 |
| Almost U., Inc. | 1 | 0 |
| Centurion Medical Products Corporation | 0 | 1 |
| Dekumed, Kunststofftechnik Degler GmbH | 1 | 0 |
| Great Bay Medical Products, Inc. | 1 | 0 |
| Hemispheres Marketing Co. , Ltd. | 1 | 0 |
| Jobst Institute, Inc. | 1 | 0 |
| Maxol Limited L.C. | 1 | 0 |
| Spenco Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 16, 1999 | K990458 | STRAUMANN EXTRAORAL IMPLANT SYSTEM Straumann USA | KCZ |
| May 26, 1995 | K951324 | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS Maxol Limited L.C. | KCZ |
| Jul 20, 1994 | K933465 | COSMET Great Bay Medical Products, Inc. | KCZ |
| Dec 22, 1993 | K932978 | CALSSIQUE OR MYSTIQUE Dekumed, Kunststofftechnik Degler GmbH, DE | KCZ |
| Dec 16, 1993 | K932899 | CLASSIQUE Hemispheres Marketing Co. , Ltd. | KCZ |
| Dec 10, 1993 | K933668 | ALMOST U, INC. BREAST PROSTHESIS Almost U., Inc. | KCZ |
| May 11, 1992 | K921535 | SUOENA AFFINITY (TM) MODEL #802 Coloplast Corp. | KCZ |
| Jan 14, 1992 | K915382 | AMOENA AFFINITY MODEL #802 Coloplast Corp. | KCZ |
| Mar 29, 1991 | K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM Jobst Institute, Inc. | KCZ |
| Oct 31, 1990 | K904085 | ELLA BREAST FORM Coloplast A/S | KCZ |
| Oct 11, 1990 | K904316 | NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT Coloplast Corp. | KCZ |
| Oct 2, 1990 | K904086 | DISCRENE SELF-SUPPORTING BREAST FORM Coloplast A/S | KCZ |
| Dec 13, 1989 | K896533 | SPENCO BREAST FORMS Spenco Medical Corp. | KCZ |
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