Elastomer, Silicone Block

FDA product code MIB · 45 cleared devices

Class 2 Ear, Nose, Throat

Regulation: 21 CFR 874.3620
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1992-04-21 – 2024-07-24

MIB 2024-07-24

MISTI Silicone Implant

Applicant Keosan Trading Co.

K number K241150

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MIB 2023-02-03

Pre-Formed Silicone Block

Applicant International Medical Devices, Inc.

K number K223051

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MIB 2022-12-23

ShiNeo Silicone Implant

Applicant Shineo Technology Co., Ltd.

K number K222748

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MIB 2022-09-30

AugMENTA Penile Implant

Applicant Augmenta, LLC

K number K200073

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MIB 2022-05-13

Pre-Formed Penile Silicone Block

Applicant International Medical Devices, Inc.

K number K220760

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MIB 2020-07-20

BioSiCar Silicone Implant

Applicant Metalware Technology Corp.

K number K193392

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MIB 2019-01-23

Pre-Formed Penile Silicone Block

Applicant International Medical Devices, Inc.

K number K181387

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MIB 2018-03-16

SOFTXIL

Applicant Bistool

K number K171851

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MIB 2017-02-01

Pre-Formed Penile Silicone Block

Applicant International Medical Devices, Inc.

K number K162624

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MIB 2005-11-04

CALF IMPLANT, MODEL EC17-X

Applicant Implantech Associates, Inc.

K number K052505

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MIB 2005-11-04

GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X

Applicant Implantech Associates, Inc.

K number K052504

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MIB 2005-02-23

SILIMED PECTORAL IMPLANT

Applicant Silimed, Inc.

K number K042054

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MIB 2004-10-25

SILICONE BLOCK

Applicant National Medical Devices, Inc.

K number K042380

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MIB 2004-04-01

MEDISIL SILICONE SHEETING

Applicant Medisil Corporation

K number K040042

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MIB 2003-04-21

HANSON MEDICAL GLUTEAL IMPLANT

Applicant Hanson Medical, Inc.

K number K030809

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MIB 2003-04-21

HANSON MEDICAL CALF IMPLANT

Applicant Hanson Medical, Inc.

K number K030808

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MIB 2002-08-26

AART CALF IMPLANT

Applicant Aesthetic and Reconstructive Technologies, Inc.

K number K022511

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MIB 2002-08-08

AART SILICONE SHEETING

Applicant Aesthetic and Reconstructive Technologies, Inc.

K number K022223

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MIB 2002-07-16

AART GLUTEAL IMPLANT

Applicant Aesthetic and Reconstructive Technologies, Inc.

K number K021839

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MIB 2002-07-16

AART SILICONE CARVING BLOCK

Applicant Aesthetic and Reconstructive Technologies, Inc.

K number K021820

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MIB 1998-12-11

SEARE BIOMEDICAL SILICONE RODS

Applicant Seare Biomedical Corp.

K number K983630

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MIB 1998-10-13

SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK

Applicant Spectrum Designs, Inc.

K number K982688

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MIB 1998-09-30

SEARE BIOMEDICAL SILICONE SHEETING

Applicant Seare Biomedical Corp.

K number K983041

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MIB 1998-08-12

STERILE SILICONE EXTERNAL WOUND COVER

Applicant Specialty Surgical Products, Inc.

K number K982065

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MIB 1998-07-09

SILIMED SILICONE CARVING BLOCK

Applicant Silimed, LLC

K number K981851

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MIB 1998-03-13

SILICONE ELASTOMER SHEETING

Applicant Specialty Surgical Products, Inc.

K number K974653

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MIB 1998-02-24

SILICONE BLOCKS

Applicant Specialty Surgical Products, Inc.

K number K974654

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MIB 1998-02-24

SILIMED GLUTEAL IMPLANT

Applicant Silimed, LLC

K number K974482

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MIB 1998-02-24

SILIMED CALF IMPLANT

Applicant Silimed, LLC

K number K974480

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MIB 1997-12-24

DURASIL I AND DURASIL II

Applicant Hanson Medical, Inc.

K number K973730

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MIB 1997-11-21

DOW CORNING SILASTIC ELASTOMER Q7-4750

Applicant Technical Products, Inc.

K number K973166

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MIB 1997-11-13

SILICONE CARVING BLOCK

Applicant Hanson Medical, Inc.

K number K973728

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MIB 1997-05-28

DURALASTIC I AND DURALASTIC II

Applicant Allied Biomedical Corp.

K number K971480

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MIB 1997-05-22

SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING

Applicant Technical Products, Inc.

K number K971613

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MIB 1996-05-22

SPIRIT RIDGE SILICONE CARVING BLOCK

Applicant Rand Scientific Corp.

K number K961081

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MIB 1996-05-16

DURALASTIC SHEETING II

Applicant Rand Scientific Corp.

K number K961057

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MIB 1996-03-13

SPECTRUM DESIGNS SILICONE BLOCK

Applicant Spectrum Designs, Inc.

K number K960038

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MIB 1996-02-08

DURALASTIC II

Applicant Allied Biomedical Corp.

K number K955370

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MIB 1996-02-08

DURALASTIC I

Applicant Allied Biomedical Corp.

K number K955368

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MIB 1995-11-29

PROLASTIC SHEETING

Applicant Pillar Surgical

K number K954382

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MIB 1995-08-31

MEDICAL GRADE SILICONE BLOCK

Applicant Bioplexus Corp.

K number K952732

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MIB 1995-01-31

DURALASTIC SHEETING

Applicant Applied Biomaterial Technologies

K number K945552

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MIB 1995-01-31

DURALASTIC SHEETING

Applicant Applied Biomaterial Technologies

K number K935571

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MIB 1994-11-09

IMPLANTECH MEDICAL GRADE SILICONE SHEETING

Applicant King & Spalding

K number K944408

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MIB 1992-04-21

ZARA SILICONE BLOCK

Applicant Byron Medical

K number K913882

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