FDA Product Code
FDA Product Code FZE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3680
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241253 | Medicon Epiplating System | Cmf Medicon Surgical, Inc. | 2024-12-12 | Traditional | PDF ↗ |
| K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | 2016-12-01 | Traditional | PDF ↗ |
| K090803 | HANSON MEDICAL FACIAL IMPLANTS | Hanson Medical, Inc. | 2010-06-30 | Traditional | PDF ↗ |
| K090630 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) | Nobel Biocare AB | 2009-06-02 | Traditional | PDF ↗ |
| K071018 | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | 2007-05-25 | Traditional | PDF ↗ |
| K041690 | MONARCH NASAL IMPLANT | Hanson Medical, Inc. | 2005-02-11 | Traditional | PDF ↗ |
| K021418 | AART NASAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K992242 | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS | Pillar Surgical, Inc. | 1999-11-22 | Traditional | PDF ↗ |
| K983755 | NASAL DORSAL SERIES | Surgical Technology Laboratories, Inc. | 1998-11-20 | Special | PDF ↗ |
| K982753 | SEARE BIOMEDICAL NASAL IMPLANTS | Seare Biomedical Corp. | 1998-09-30 | Traditional | PDF ↗ |
| K981833 | SILIMED NASAL L SHAPED IMPLANT | Silimed, LLC | 1998-06-26 | Traditional | PDF ↗ |
| K973573 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Hanson Medical, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K971481 | DURALASTIC ANATOMICAL NASAL IMPLANTS | Allied Biomedical Corp. | 1997-07-18 | Traditional | PDF ↗ |
| K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | Implantech Associates, Inc. | 1996-10-03 | Traditional | PDF ↗ |
| K961124 | THE NAUTILUS | Rand Scientific Corp. | 1996-04-19 | Traditional | PDF ↗ |
| K952705 | SPIRIT RIDGE NASAL IMPLANT | Spirit Ridge Technologies | 1995-08-28 | Traditional | PDF ↗ |
| K952706 | SPIRIT RIDGE SILICONE CARVING BLOCK | Spirit Ridge Technologies | 1995-08-28 | Traditional | PDF ↗ |
| K952708 | PECTORALIS IMPLANT | Spirit Ridge Technologies | 1995-08-28 | Traditional | PDF ↗ |
| K952707 | SILICONE ELASTOMER MALAR IMPLANT | Spirit Ridge Technologies | 1995-08-28 | Traditional | PDF ↗ |
| K952709 | PROTHESIS, CHIN, INTERNAL | Spirit Ridge Technologies | 1995-08-28 | Traditional | PDF ↗ |
| K945154 | BA-CPAS | Nobelpharma USA, Inc. | 1995-01-13 | Traditional | PDF ↗ |
| K941960 | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II | Implantech Associates, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K942876 | IMPLANTECH DORSAL NASAL IMPLANT | Implantech Associates, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K925743 | NASAL DORSUM | Smith & Nephew Richards, Inc. | 1993-08-10 | Traditional | PDF ↗ |
| K925426 | RIZZO NASAL IMPLANT | Implantech Associates, Inc. | 1993-05-12 | Traditional | PDF ↗ |
| K921580 | BRINK PRE-MAXILLARY IMPLANT | Implantech Associates, Inc. | 1992-05-06 | Traditional | PDF ↗ |
| K904657 | FLOWERS DORSAL COLUMELLA IMPLANT | Implantech Associates, Inc. | 1990-12-18 | Traditional | PDF ↗ |
| K904656 | FLOWERS NASAL IMPLANT | Implantech Associates, Inc. | 1990-12-18 | Traditional | PDF ↗ |
| K904350 | CUI DORSAL COLUMELLA PROSTHESIS | Cui Corp. | 1990-11-26 | Traditional | PDF ↗ |
| K903328 | CUI PREMAXILLARY IMPLANT | Cui Corp. | 1990-09-10 | Traditional | PDF ↗ |
| K902283 | THE NAUTILUS NASAL IMPLANT | Applied Biomaterial Technologies | 1990-08-14 | Traditional | PDF ↗ |
| K880405 | SILASTIC NASAL IMPLANT S-TYPE | Dow Corning Wright | 1988-02-18 | Traditional | PDF ↗ |
| K871071 | OMEGA DORSAL COLUMELLA IMPLANTS | Omega Silicone, Inc. | 1987-04-13 | Traditional | PDF ↗ |
| K863942 | POREX(TM) NOSE PROSTHESIS | Porex Medical | 1986-10-24 | Traditional | PDF ↗ |
| K863430 | BYRON BIVALVE NASAL SPLINTS | Byron Medical | 1986-09-17 | Traditional | PDF ↗ |
| K863398 | BYRON NASAL SEPTAL BUTTON | Byron Medical | 1986-09-17 | Traditional | PDF ↗ |
| K863399 | BYRON DORSAL COLUMELLA IMPLANT | Byron Medical | 1986-09-17 | Traditional | PDF ↗ |
| K853945 | CUI RHINOPLASTY IMPLANTS | Cox-Uphuff Intl. | 1985-10-18 | Traditional | PDF ↗ |
| K822130 | FRANCIS NASAL TUBE | Tekna Med Corp. | 1982-10-13 | Traditional | PDF ↗ |
| K801074 | STRAITH NASAL IMPLANT | Surgical Technology Laboratories, Inc. | 1980-06-17 | Traditional | PDF ↗ |
| K782104 | PASTE, PRO CARE PROPHYLAXIS | Young Dental Manufacturing Co. 1, LLC | 1979-01-03 | Traditional | PDF ↗ |
| K781574 | PLASTI-PORE SEPTAL BUTTON | Richard'S Medical Equip., Inc. | 1978-09-27 | Traditional | PDF ↗ |
Product code FZE · Class II · General, Plastic Surgery. Data: openFDA.