Medical Device Manufacturer · US , Cincinnati , OH

Standard Textile Co., Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1986
23
Total
23
Cleared
0
Denied

FDA 510(k) cleared devices by Standard Textile Co., Inc. General Hospital

22 devices
1-22 of 22
Cleared Sep 10, 2024
ProPel SG3™ Surgical Gown
K241214 · FYA
General Hospital · 133d
Cleared Aug 25, 2017
Standard Supreme Sterilization Wrapper
K172207 · FRG
General Hospital · 35d
Cleared Nov 04, 2016
Barrier Supreme Sterilization Wrapper
K162162 · FRG
General Hospital · 94d
Cleared Mar 07, 2006
COMPE1 1 -PLY SURGICAL GOWNS
K060181 · FYA
General Hospital · 43d
Cleared Jul 01, 2005
COMPEL 1-PLY SURGICAL GOWNS
K041653 · FYA
General Hospital · 379d
Cleared May 05, 2005
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
K041540 · FYA
General Hospital · 331d
Cleared Apr 28, 2005
COMPEL SURGICAL GOWNS
K041539 · FYA
General Hospital · 324d
Cleared Mar 16, 2005
COMPEL MLR SURGICAL GOWNS
K041541 · FYA
General Hospital · 281d
Cleared Dec 03, 2001
TRIMAX
K012268 · FYA
General Hospital · 137d
Cleared Oct 11, 2001
MODIFICATION TO: COMPEL SURGICAL DRAPES
K012807 · KKX
General Hospital · 50d
Cleared Jun 07, 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · FYA
General Hospital · 83d
Cleared Feb 26, 1998
PROMAX SURGICAL DRAPES AND COVERS
K980183 · KKX
General Hospital · 37d
Cleared Apr 27, 1995
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
K945371 · FYA
General Hospital · 176d
Cleared Apr 25, 1995
PERVAL SURGICAL GOWN (MARKETING NAME)
K950504 · FYA
General Hospital · 78d
Cleared Feb 28, 1995
COMPEL SURGICALDRAPES
K944863 · KKX
General Hospital · 148d
Cleared Apr 22, 1994
COMPEL SURGICAL GOWNS
K940758 · FYA
General Hospital · 63d
Cleared Apr 08, 1993
WRAPPEL T
K923408 · FRG
General Hospital · 272d
Cleared Mar 09, 1993
COMPEL XTR
K922753 · FYA
General Hospital · 274d
Cleared Feb 23, 1993
COMPEL SURGICAL DRAPES
K923811 · KKX
General Hospital · 209d
Cleared Feb 18, 1993
COMPEL O AND R
K921889 · FYA
General Hospital · 302d
Cleared Apr 02, 1992
COMPEL E
K914839 · FYA
General Hospital · 160d
Cleared Feb 19, 1986
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
K860447 · KKX
General Hospital · 15d
Filters