MIB · Class II · 21 CFR 874.3620

FDA Product Code MIB: Elastomer, Silicone Block

Leading manufacturers include Aesthetic and Reconstructive Technologies, Inc., International Medical Devices, Inc. and Allied Biomedical Corp..

45
Total
45
Cleared
113d
Avg days
1992
Since
45 devices
25–45 of 45
Cleared Feb 24, 1998
SILIMED GLUTEAL IMPLANT
K974482
Silimed, LLC
General & Plastic Surgery · 90d
Cleared Feb 24, 1998
SILICONE BLOCKS
K974654
Specialty Surgical Products, Inc.
General & Plastic Surgery · 71d
Cleared Dec 24, 1997
DURASIL I AND DURASIL II
K973730
Hanson Medical, Inc.
General & Plastic Surgery · 85d
Cleared Nov 21, 1997
DOW CORNING SILASTIC ELASTOMER Q7-4750
K973166
Technical Products, Inc.
General & Plastic Surgery · 88d
Cleared Nov 13, 1997
SILICONE CARVING BLOCK
K973728
Hanson Medical, Inc.
General & Plastic Surgery · 44d
Cleared May 28, 1997
DURALASTIC I AND DURALASTIC II
K971480
Allied Biomedical Corp.
General & Plastic Surgery · 35d
Cleared May 22, 1997
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING
K971613
Technical Products, Inc.
General & Plastic Surgery · 20d
Cleared May 22, 1996
SPIRIT RIDGE SILICONE CARVING BLOCK
K961081
Rand Scientific Corp.
General & Plastic Surgery · 65d
Cleared May 16, 1996
DURALASTIC SHEETING II
K961057
Rand Scientific Corp.
General & Plastic Surgery · 59d
Cleared Mar 13, 1996
SPECTRUM DESIGNS SILICONE BLOCK
K960038
Spectrum Designs, Inc.
General & Plastic Surgery · 70d
Cleared Feb 08, 1996
DURALASTIC I
K955368
Allied Biomedical Corp.
General & Plastic Surgery · 78d
Cleared Feb 08, 1996
DURALASTIC II
K955370
Allied Biomedical Corp.
General & Plastic Surgery · 78d
Cleared Apr 21, 1992
ZARA SILICONE BLOCK
K913882
Byron Medical
General & Plastic Surgery · 236d