FDA Product Code
FDA Product Code MIB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3620
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241150 | MISTI Silicone Implant | Keosan Trading Co. | 2024-07-24 | Traditional | PDF ↗ |
| K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | 2023-02-03 | Traditional | PDF ↗ |
| K222748 | ShiNeo Silicone Implant | Shineo Technology Co., Ltd. | 2022-12-23 | Traditional | PDF ↗ |
| K200073 | AugMENTA Penile Implant | Augmenta, LLC | 2022-09-30 | Traditional | PDF ↗ |
| K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2022-05-13 | Traditional | PDF ↗ |
| K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | 2020-07-20 | Traditional | PDF ↗ |
| K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019-01-23 | Traditional | PDF ↗ |
| K171851 | SOFTXIL | Bistool | 2018-03-16 | Traditional | PDF ↗ |
| K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017-02-01 | Traditional | PDF ↗ |
| K052505 | CALF IMPLANT, MODEL EC17-X | Implantech Associates, Inc. | 2005-11-04 | Traditional | PDF ↗ |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | Implantech Associates, Inc. | 2005-11-04 | Traditional | PDF ↗ |
| K042054 | SILIMED PECTORAL IMPLANT | Silimed, Inc. | 2005-02-23 | Traditional | PDF ↗ |
| K042380 | SILICONE BLOCK | National Medical Devices, Inc. | 2004-10-25 | Traditional | PDF ↗ |
| K040042 | MEDISIL SILICONE SHEETING | Medisil Corporation | 2004-04-01 | Traditional | PDF ↗ |
| K030808 | HANSON MEDICAL CALF IMPLANT | Hanson Medical, Inc. | 2003-04-21 | Traditional | PDF ↗ |
| K030809 | HANSON MEDICAL GLUTEAL IMPLANT | Hanson Medical, Inc. | 2003-04-21 | Traditional | PDF ↗ |
| K022511 | AART CALF IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-08-26 | Traditional | PDF ↗ |
| K022223 | AART SILICONE SHEETING | Aesthetic and Reconstructive Technologies, Inc. | 2002-08-08 | Traditional | PDF ↗ |
| K021839 | AART GLUTEAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-16 | Traditional | PDF ↗ |
| K021820 | AART SILICONE CARVING BLOCK | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-16 | Traditional | PDF ↗ |
| K983630 | SEARE BIOMEDICAL SILICONE RODS | Seare Biomedical Corp. | 1998-12-11 | Traditional | PDF ↗ |
| K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK | Spectrum Designs, Inc. | 1998-10-13 | Traditional | PDF ↗ |
| K983041 | SEARE BIOMEDICAL SILICONE SHEETING | Seare Biomedical Corp. | 1998-09-30 | Traditional | PDF ↗ |
| K982065 | STERILE SILICONE EXTERNAL WOUND COVER | Specialty Surgical Products, Inc. | 1998-08-12 | Traditional | PDF ↗ |
| K981851 | SILIMED SILICONE CARVING BLOCK | Silimed, LLC | 1998-07-09 | Traditional | PDF ↗ |
| K974653 | SILICONE ELASTOMER SHEETING | Specialty Surgical Products, Inc. | 1998-03-13 | Traditional | PDF ↗ |
| K974654 | SILICONE BLOCKS | Specialty Surgical Products, Inc. | 1998-02-24 | Traditional | PDF ↗ |
| K974480 | SILIMED CALF IMPLANT | Silimed, LLC | 1998-02-24 | Traditional | PDF ↗ |
| K974482 | SILIMED GLUTEAL IMPLANT | Silimed, LLC | 1998-02-24 | Traditional | PDF ↗ |
| K973730 | DURASIL I AND DURASIL II | Hanson Medical, Inc. | 1997-12-24 | Traditional | PDF ↗ |
| K973166 | DOW CORNING SILASTIC ELASTOMER Q7-4750 | Technical Products, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K973728 | SILICONE CARVING BLOCK | Hanson Medical, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K971480 | DURALASTIC I AND DURALASTIC II | Allied Biomedical Corp. | 1997-05-28 | Traditional | PDF ↗ |
| K971613 | SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING | Technical Products, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K961081 | SPIRIT RIDGE SILICONE CARVING BLOCK | Rand Scientific Corp. | 1996-05-22 | Traditional | PDF ↗ |
| K961057 | DURALASTIC SHEETING II | Rand Scientific Corp. | 1996-05-16 | Traditional | PDF ↗ |
| K960038 | SPECTRUM DESIGNS SILICONE BLOCK | Spectrum Designs, Inc. | 1996-03-13 | Traditional | PDF ↗ |
| K955370 | DURALASTIC II | Allied Biomedical Corp. | 1996-02-08 | Traditional | PDF ↗ |
| K955368 | DURALASTIC I | Allied Biomedical Corp. | 1996-02-08 | Traditional | PDF ↗ |
| K954382 | PROLASTIC SHEETING | Pillar Surgical | 1995-11-29 | Traditional | PDF ↗ |
| K952732 | MEDICAL GRADE SILICONE BLOCK | Bioplexus Corp. | 1995-08-31 | Traditional | PDF ↗ |
| K935571 | DURALASTIC SHEETING | Applied Biomaterial Technologies | 1995-01-31 | Traditional | PDF ↗ |
| K945552 | DURALASTIC SHEETING | Applied Biomaterial Technologies | 1995-01-31 | Traditional | PDF ↗ |
| K944408 | IMPLANTECH MEDICAL GRADE SILICONE SHEETING | King & Spalding | 1994-11-09 | Traditional | PDF ↗ |
| K913882 | ZARA SILICONE BLOCK | Byron Medical | 1992-04-21 | Traditional | PDF ↗ |
Product code MIB · Class II · Ear, Nose, Throat. Data: openFDA.