ITG · Class I · 21 CFR 890.3025

FDA Product Code ITG: Bandage, Cast

Leading manufacturers include Johnson & Johnson Professionals, Inc., Zimmer, Inc. and Cutter 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 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 Feb 04, 1982
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
K813052
Zimmer, Inc.
Physical Medicine · 98d
Cleared Jul 20, 1981
CRYSTONA
K811754
Smith & Nephew, Inc.
Physical Medicine · 28d
Cleared Sep 24, 1979
PROCAST
K791831
Medical Specialties, Inc.
Physical Medicine · 6d
Cleared Jul 30, 1979
FELTLOC CAST PADDING
K791305
Howmedica Corp.
Physical Medicine · 14d
Cleared Jul 24, 1979
3M ORTHOPEDIC CASTING TAPE
K791094
3M Company
Physical Medicine · 42d
Cleared May 18, 1979
DELTA-LITE
K790320
Johnson & Johnson Professionals, Inc.
Physical Medicine · 92d
Cleared Jun 02, 1977
BANDAGES, SPEC. X-TRA HARD OR PLASTER
K770929
Johnson & Johnson Professionals, Inc.
Physical Medicine · 10d
Cleared Apr 28, 1977
CUTTER CAST 7
K770742
Cutter Laboratories, Inc.
Physical Medicine · 6d
Cleared Feb 28, 1977
BANDAGES, PLASTER OF PARIS & SPLINTS
K770340
Johnson & Johnson Professionals, Inc.
Physical Medicine · 10d
Cleared Jul 26, 1976
CAST MATERIAL (WICKET STOCKINETTE)
K760003
Zimmer, Inc.
Physical Medicine · 61d

About Product Code ITG - Regulatory Context