ITG · Class I · 21 CFR 890.3025

FDA Product Code ITG: Bandage, Cast

Leading manufacturers include Hexcel Medical, Secol Co. and Solar Laboratories, Inc..

37
Total
37
Cleared
40d
Avg days
1976
Since

FDA 510(k) Cleared Bandage, Cast Devices (Product Code ITG)

37 devices
1–24 of 37
Cleared Oct 09, 1987
CONFORMA(TM) PLASTER BANDAGES
K873111
The Kendal Co.
Physical Medicine · 60d
Cleared Aug 19, 1986
DEKNA BAND KIT
K862115
Deknatel, Inc.
Physical Medicine · 77d
Cleared Aug 10, 1984
T.P.G. CAST TAPE
K842573
The Poly Group, Inc.
Physical Medicine · 38d
Cleared Mar 23, 1984
HEXCELITE
K840416
Hexcel Medical
Physical Medicine · 52d
Cleared Dec 12, 1983
NON WETTING UNDERCAST PADDING
K833732
American Medical Disposable, Inc.
Physical Medicine · 48d
Cleared Nov 14, 1983
SOFFBAN ORTHOPEDIC PADDING
K832992
Smith & Nephew, Inc.
Physical Medicine · 73d
Cleared Aug 16, 1983
ORTHOPEDIC CASTING TAPE MAXCAST
K832237
Cutter Laboratories, Inc.
Physical Medicine · 36d
Cleared Jul 07, 1983
SUPPORT PRODUCTS EXAMPLE PROSET CAST
K830650
Isopedix Corp.
Physical Medicine · 126d
Cleared Jun 30, 1983
YESONA PLASTER OF PARIS BANDAGE
K831492
Watson Phillips Y Cia. Sucs., S.A. DE C.V.
Physical Medicine · 51d
Cleared Jun 23, 1982
URETHANE ORTHOPAEDIC CASTING TAPE
K820890
Hexcel Medical
Physical Medicine · 85d
Cleared Feb 12, 1982
WEBRIL CAST PADDING
K820140
Stan-Pak Ent.
Physical Medicine · 24d
Cleared Feb 12, 1982
SPECIALIST CAST PADDING
K820155
Stan-Pak Ent.
Physical Medicine · 24d
Cleared Feb 04, 1982
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
K813052
Zimmer, Inc.
Physical Medicine · 98d
Cleared Dec 17, 1981
CARAFLEX ELASTIC POLYMER PLASTER BANDA
K813219
Carapace, Inc.
Physical Medicine · 38d
Cleared Jul 20, 1981
CRYSTONA
K811754
Smith & Nephew, Inc.
Physical Medicine · 28d
Cleared May 27, 1981
URETHANE ORTHOPAEDIC CASTING TAPE
K811164
Hexcel Medical
Physical Medicine · 29d
Cleared Apr 17, 1981
ORTHOSIS BANDAGES
K810877
Ortho-Cast, Inc.
Physical Medicine · 17d
Cleared Feb 04, 1981
CELLONA PLASTER VARNISH
K810111
Secol Co.
Physical Medicine · 19d
Cleared Dec 10, 1980
CELLONA
K802792
Secol Co.
Physical Medicine · 36d
Cleared Nov 24, 1980
CELLAMIN
K802796
Secol Co.
Physical Medicine · 20d
Cleared Jul 28, 1980
IPOCON 7
K800749
Ipos Luneburg
Physical Medicine · 115d
Cleared May 02, 1980
BVN
K800695
Donald J. Mangus, M.D.
Physical Medicine · 35d
Cleared Apr 21, 1980
PRE-PADDED PLASTER/PARIS BAND/SPLINTS
K800752
Ortho-Care, Inc.
Physical Medicine · 17d
Cleared Feb 11, 1980
COTTON UNDER CAST PADDING
K800195
Winn Hirsch & Assoc.
Physical Medicine · 13d

About Product Code ITG - Regulatory Context