Panels › Ear, Nose, Throat › Product code MIB · Class 2
Elastomer, Silicone Block
Regulation 874.3620
0510(k)s in 12 months (45 all time)
3recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in MIB
| Company | 510(k)s | Recalls |
|---|---|---|
| Aesthetic and Reconstructive Technologies, Inc. | 4 | 0 |
| Hanson Medical, Inc. | 4 | 0 |
| International Medical Devices, Inc. | 4 | 0 |
| Silimed, Inc. | 4 | 0 |
| Allied Biomedical Corp. | 3 | 0 |
| DSAART LLC | 0 | 3 |
| Specialty Surgical Products, Inc. | 3 | 0 |
| Applied Biomaterial Technologies | 2 | 0 |
| Implantech Associates, Inc. | 2 | 0 |
| Rand Scientific Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2024 | K241150 | MISTI Silicone Implant Keosan Trading Co., KR | MIB |
| Feb 3, 2023 | K223051 | Pre-Formed Silicone Block International Medical Devices, Inc. | MIB |
| Dec 23, 2022 | K222748 | ShiNeo Silicone Implant Shineo Technology Co., Ltd., TW | MIB |
| Sep 30, 2022 | K200073 | AugMENTA Penile Implant Augmenta, LLC | MIB |
| May 13, 2022 | K220760 | Pre-Formed Penile Silicone Block International Medical Devices, Inc. | MIB |
| Jul 20, 2020 | K193392 | BioSiCar Silicone Implant Metalware Technology Corp., TW | MIB |
| Jan 23, 2019 | K181387 | Pre-Formed Penile Silicone Block International Medical Devices, Inc. | MIB |
| Mar 16, 2018 | K171851 | SOFTXIL Bistool, KR | MIB |
| Feb 1, 2017 | K162624 | Pre-Formed Penile Silicone Block International Medical Devices, Inc. | MIB |
| Nov 4, 2005 | K052505 | CALF IMPLANT, MODEL EC17-X Implantech Associates, Inc. | MIB |
| Nov 4, 2005 | K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X Implantech Associates, Inc. | MIB |
| Feb 23, 2005 | K042054 | SILIMED PECTORAL IMPLANT Silimed, Inc. | MIB |
| Oct 25, 2004 | K042380 | SILICONE BLOCK National Medical Devices, Inc. | MIB |
| Apr 1, 2004 | K040042 | MEDISIL SILICONE SHEETING Medisil Corporation | MIB |
| Apr 21, 2003 | K030809 | HANSON MEDICAL GLUTEAL IMPLANT Hanson Medical, Inc. | MIB |
| Apr 21, 2003 | K030808 | HANSON MEDICAL CALF IMPLANT Hanson Medical, Inc. | MIB |
| Aug 26, 2002 | K022511 | AART CALF IMPLANT Aesthetic and Reconstructive Technologies, Inc. | MIB |
| Aug 8, 2002 | K022223 | AART SILICONE SHEETING Aesthetic and Reconstructive Technologies, Inc. | MIB |
| Jul 16, 2002 | K021839 | AART GLUTEAL IMPLANT Aesthetic and Reconstructive Technologies, Inc. | MIB |
| Jul 16, 2002 | K021820 | AART SILICONE CARVING BLOCK Aesthetic and Reconstructive Technologies, Inc. | MIB |
| Dec 11, 1998 | K983630 | SEARE BIOMEDICAL SILICONE RODS Seare Biomedical Corp. | MIB |
| Oct 13, 1998 | K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK Spectrum Designs, Inc. | MIB |
| Sep 30, 1998 | K983041 | SEARE BIOMEDICAL SILICONE SHEETING Seare Biomedical Corp. | MIB |
| Aug 12, 1998 | K982065 | STERILE SILICONE EXTERNAL WOUND COVER Specialty Surgical Products, Inc. | MIB |
| Jul 9, 1998 | K981851 | SILIMED SILICONE CARVING BLOCK Silimed, LLC | MIB |
| Mar 13, 1998 | K974653 | SILICONE ELASTOMER SHEETING Specialty Surgical Products, Inc. | MIB |
| Feb 24, 1998 | K974654 | SILICONE BLOCKS Specialty Surgical Products, Inc. | MIB |
| Feb 24, 1998 | K974482 | SILIMED GLUTEAL IMPLANT Silimed, LLC | MIB |
| Feb 24, 1998 | K974480 | SILIMED CALF IMPLANT Silimed, LLC | MIB |
| Dec 24, 1997 | K973730 | DURASIL I AND DURASIL II Hanson Medical, Inc. | MIB |
| Nov 21, 1997 | K973166 | DOW CORNING SILASTIC ELASTOMER Q7-4750 Technical Products, Inc. | MIB |
| Nov 13, 1997 | K973728 | SILICONE CARVING BLOCK Hanson Medical, Inc. | MIB |
| May 28, 1997 | K971480 | DURALASTIC I AND DURALASTIC II Allied Biomedical Corp. | MIB |
| May 22, 1997 | K971613 | SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING Technical Products, Inc. | MIB |
| May 22, 1996 | K961081 | SPIRIT RIDGE SILICONE CARVING BLOCK Rand Scientific Corp. | MIB |
| May 16, 1996 | K961057 | DURALASTIC SHEETING II Rand Scientific Corp. | MIB |
| Mar 13, 1996 | K960038 | SPECTRUM DESIGNS SILICONE BLOCK Spectrum Designs, Inc. | MIB |
| Feb 8, 1996 | K955370 | DURALASTIC II Allied Biomedical Corp. | MIB |
| Feb 8, 1996 | K955368 | DURALASTIC I Allied Biomedical Corp. | MIB |
| Nov 29, 1995 | K954382 | PROLASTIC SHEETING Pillar Surgical | MIB |
| Aug 31, 1995 | K952732 | MEDICAL GRADE SILICONE BLOCK Bioplexus Corp. | MIB |
| Jan 31, 1995 | K945552 | DURALASTIC SHEETING Applied Biomaterial Technologies | MIB |
| Jan 31, 1995 | K935571 | DURALASTIC SHEETING Applied Biomaterial Technologies | MIB |
| Nov 9, 1994 | K944408 | IMPLANTECH MEDICAL GRADE SILICONE SHEETING King & Spalding | MIB |
| Apr 21, 1992 | K913882 | ZARA SILICONE BLOCK Byron Medical | MIB |
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