MIB

Pre-Formed Penile Silicone Block

Advisory panel: Ear, Nose, Throat
Total cleared: 45

Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MIB

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.