Panels › General, Plastic Surgery › Product code FZE · Class 2
Prosthesis, Nose, Internal
Regulation 878.3680
0510(k)s in 12 months (42 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Implantech Associates, Inc. | 7 | 0 |
| Spirit Ridge Technologies | 5 | 0 |
| Hanson Medical, Inc. | 4 | 0 |
| Byron Medical | 3 | 0 |
| Cui Corp. | 2 | 0 |
| Surgical Technology Laboratories, Inc. | 2 | 0 |
| Aesthetic and Reconstructive Technologies, Inc. | 1 | 0 |
| Allied Biomedical Corp. | 1 | 0 |
| Applied Biomaterial Technologies | 1 | 0 |
| Cmf Medicon Surgical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 2024 | K241253 | Medicon Epiplating System Cmf Medicon Surgical, Inc. | FZE |
| Dec 1, 2016 | K161548 | Osseointegrated Fixtures Southern Implants (Pty), Ltd., ZA | FZE |
| Jun 30, 2010 | K090803 | HANSON MEDICAL FACIAL IMPLANTS Hanson Medical, Inc. | FZE |
| Jun 2, 2009 | K090630 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) Nobel Biocare AB | FZE |
| May 25, 2007 | K071018 | MONARCH NASAL IMPLANT Hanson Medical, Inc. | FZE |
| Feb 11, 2005 | K041690 | MONARCH NASAL IMPLANT Hanson Medical, Inc. | FZE |
| Jul 2, 2002 | K021418 | AART NASAL IMPLANT Aesthetic and Reconstructive Technologies, Inc. | FZE |
| Nov 22, 1999 | K992242 | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS Pillar Surgical, Inc. | FZE |
| Nov 20, 1998 | K983755 | NASAL DORSAL SERIES Surgical Technology Laboratories, Inc. | FZE |
| Sep 30, 1998 | K982753 | SEARE BIOMEDICAL NASAL IMPLANTS Seare Biomedical Corp. | FZE |
| Jun 26, 1998 | K981833 | SILIMED NASAL L SHAPED IMPLANT Silimed, LLC | FZE |
| Nov 13, 1997 | K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS Hanson Medical, Inc. | FZE |
| Jul 18, 1997 | K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS Allied Biomedical Corp. | FZE |
| Oct 3, 1996 | K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT Implantech Associates, Inc. | FZE |
| Apr 19, 1996 | K961124 | THE NAUTILUS Rand Scientific Corp. | FZE |
| Aug 28, 1995 | K952709 | PROTHESIS, CHIN, INTERNAL Spirit Ridge Technologies | FZE |
| Aug 28, 1995 | K952708 | PECTORALIS IMPLANT Spirit Ridge Technologies | FZE |
| Aug 28, 1995 | K952707 | SILICONE ELASTOMER MALAR IMPLANT Spirit Ridge Technologies | FZE |
| Aug 28, 1995 | K952706 | SPIRIT RIDGE SILICONE CARVING BLOCK Spirit Ridge Technologies | FZE |
| Aug 28, 1995 | K952705 | SPIRIT RIDGE NASAL IMPLANT Spirit Ridge Technologies | FZE |
| Jan 13, 1995 | K945154 | BA-CPAS Nobelpharma USA, Inc. | FZE |
| Aug 17, 1994 | K941960 | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II Implantech Associates, Inc. | FZE |
| Jul 18, 1994 | K942876 | IMPLANTECH DORSAL NASAL IMPLANT Implantech Associates, Inc. | FZE |
| Aug 10, 1993 | K925743 | NASAL DORSUM Smith & Nephew Richards, Inc. | FZE |
| May 12, 1993 | K925426 | RIZZO NASAL IMPLANT Implantech Associates, Inc. | FZE |
| May 6, 1992 | K921580 | BRINK PRE-MAXILLARY IMPLANT Implantech Associates, Inc. | FZE |
| Dec 18, 1990 | K904657 | FLOWERS DORSAL COLUMELLA IMPLANT Implantech Associates, Inc. | FZE |
| Dec 18, 1990 | K904656 | FLOWERS NASAL IMPLANT Implantech Associates, Inc. | FZE |
| Nov 26, 1990 | K904350 | CUI DORSAL COLUMELLA PROSTHESIS Cui Corp. | FZE |
| Sep 10, 1990 | K903328 | CUI PREMAXILLARY IMPLANT Cui Corp. | FZE |
| Aug 14, 1990 | K902283 | THE NAUTILUS NASAL IMPLANT Applied Biomaterial Technologies | FZE |
| Feb 18, 1988 | K880405 | SILASTIC NASAL IMPLANT S-TYPE Dow Corning Wright | FZE |
| Apr 13, 1987 | K871071 | OMEGA DORSAL COLUMELLA IMPLANTS Omega Silicone, Inc. | FZE |
| Oct 24, 1986 | K863942 | POREX(TM) NOSE PROSTHESIS Porex Medical | FZE |
| Sep 17, 1986 | K863430 | BYRON BIVALVE NASAL SPLINTS Byron Medical | FZE |
| Sep 17, 1986 | K863399 | BYRON DORSAL COLUMELLA IMPLANT Byron Medical | FZE |
| Sep 17, 1986 | K863398 | BYRON NASAL SEPTAL BUTTON Byron Medical | FZE |
| Oct 18, 1985 | K853945 | CUI RHINOPLASTY IMPLANTS Cox-Uphuff Intl. | FZE |
| Oct 13, 1982 | K822130 | FRANCIS NASAL TUBE Tekna Med Corp. | FZE |
| Jun 17, 1980 | K801074 | STRAITH NASAL IMPLANT Surgical Technology Laboratories, Inc. | FZE |
| Jan 3, 1979 | K782104 | PASTE, PRO CARE PROPHYLAXIS Young Dental Manufacturing Co. 1, LLC | FZE |
| Sep 27, 1978 | K781574 | PLASTI-PORE SEPTAL BUTTON Richard'S Medical Equip., Inc. | FZE |
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