Atlas FDA

MIB

45 FDA 510(k) clearances · Product code

71 daysmedian time to decision
236 days90th percentile
45clearances measured

FDA profile

Official device name
Elastomer, Silicone Block
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3620
Medical specialty
Ear, Nose, Throat
Flags
Implant
Adverse events (MAUDE)
1996: 2 · 2002: 3 · 2022: 19 · 2023: 74 · 2024: 32 · 2025: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MISTI Silicone Implant (K241150)Keosan Trading Co.2024-07-24
Pre-Formed Silicone Block (K223051)International Medical Devices, Inc.2023-02-03
ShiNeo Silicone Implant (K222748)Shineo Technology Co., Ltd.2022-12-23
AugMENTA Penile Implant (K200073)Augmenta, LLC2022-09-30
Pre-Formed Penile Silicone Block (K220760)International Medical Devices, Inc.2022-05-13
BioSiCar Silicone Implant (K193392)Metalware Technology Corp.2020-07-20
Pre-Formed Penile Silicone Block (K181387)International Medical Devices, Inc.2019-01-23
SOFTXIL (K171851)Bistool2018-03-16
Pre-Formed Penile Silicone Block (K162624)International Medical Devices, Inc.2017-02-01
CALF IMPLANT, MODEL EC17-X (K052505)Implantech Associates, Inc.2005-11-04
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (K052504)Implantech Associates, Inc.2005-11-04
SILIMED PECTORAL IMPLANT (K042054)Silimed, Inc.2005-02-23
SILICONE BLOCK (K042380)National Medical Devices, Inc.2004-10-25
MEDISIL SILICONE SHEETING (K040042)Medisil Corporation2004-04-01
HANSON MEDICAL CALF IMPLANT (K030808)Hanson Medical, Inc.2003-04-21
HANSON MEDICAL GLUTEAL IMPLANT (K030809)Hanson Medical, Inc.2003-04-21
AART CALF IMPLANT (K022511)Aesthetic and Reconstructive Technologies, Inc.2002-08-26
AART SILICONE SHEETING (K022223)Aesthetic and Reconstructive Technologies, Inc.2002-08-08
AART SILICONE CARVING BLOCK (K021820)Aesthetic and Reconstructive Technologies, Inc.2002-07-16
AART GLUTEAL IMPLANT (K021839)Aesthetic and Reconstructive Technologies, Inc.2002-07-16
SEARE BIOMEDICAL SILICONE RODS (K983630)Seare Biomedical Corp.1998-12-11
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK (K982688)Spectrum Designs, Inc.1998-10-13
SEARE BIOMEDICAL SILICONE SHEETING (K983041)Seare Biomedical Corp.1998-09-30
STERILE SILICONE EXTERNAL WOUND COVER (K982065)Specialty Surgical Products, Inc.1998-08-12
SILIMED SILICONE CARVING BLOCK (K981851)Silimed, LLC1998-07-09
SILICONE ELASTOMER SHEETING (K974653)Specialty Surgical Products, Inc.1998-03-13
SILIMED CALF IMPLANT (K974480)Silimed, LLC1998-02-24
SILIMED GLUTEAL IMPLANT (K974482)Silimed, LLC1998-02-24
SILICONE BLOCKS (K974654)Specialty Surgical Products, Inc.1998-02-24
DURASIL I AND DURASIL II (K973730)Hanson Medical, Inc.1997-12-24
DOW CORNING SILASTIC ELASTOMER Q7-4750 (K973166)Technical Products, Inc.1997-11-21
SILICONE CARVING BLOCK (K973728)Hanson Medical, Inc.1997-11-13
DURALASTIC I AND DURALASTIC II (K971480)Allied Biomedical Corp.1997-05-28
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING (K971613)Technical Products, Inc.1997-05-22
SPIRIT RIDGE SILICONE CARVING BLOCK (K961081)Rand Scientific Corp.1996-05-22
DURALASTIC SHEETING II (K961057)Rand Scientific Corp.1996-05-16
SPECTRUM DESIGNS SILICONE BLOCK (K960038)Spectrum Designs, Inc.1996-03-13
DURALASTIC I (K955368)Allied Biomedical Corp.1996-02-08
DURALASTIC II (K955370)Allied Biomedical Corp.1996-02-08
PROLASTIC SHEETING (K954382)Pillar Surgical1995-11-29
MEDICAL GRADE SILICONE BLOCK (K952732)Bioplexus Corp.1995-08-31
DURALASTIC SHEETING (K935571)Applied Biomaterial Technologies1995-01-31
DURALASTIC SHEETING (K945552)Applied Biomaterial Technologies1995-01-31
IMPLANTECH MEDICAL GRADE SILICONE SHEETING (K944408)King & Spalding1994-11-09
ZARA SILICONE BLOCK (K913882)Byron Medical1992-04-21

Track MIB automatically

Every clearance here is in the API, with alerts when new ones post.