KME · Class I · 21 CFR 880.6060

FDA Product Code KME: Bedding, Disposable, Medical

Leading manufacturers include Sancella, Inc., Kimberly-Clark Corp. and Haz-Med, Inc..

65
Total
65
Cleared
58d
Avg days
1976
Since

FDA 510(k) Cleared Bedding, Disposable, Medical Devices (Product Code KME)

65 devices
1–24 of 65
Cleared Sep 17, 2004
READY-HEAT BLANKET
K042145
Techtrade, LLC
General Hospital · 39d
Cleared Dec 02, 1994
OREX MEDICAL BEDDING
K944953
Thantex Specialties, Inc.
General Hospital · 56d
Cleared Jan 26, 1994
DISPOSE-A-SHEET
K933636
Belmac Healthcare Corp.
General Hospital · 183d
Cleared Nov 02, 1993
DOCTOR DOWN --RESCUE WRAP
K932539
Three Dog Down
General Hospital · 160d
Cleared Aug 10, 1992
AMERICAN BURN SHEET
K922143
American Silk Sutures, Inc.
General Hospital · 96d
Cleared Feb 20, 1992
FOIL BABY BUNTING
K915303
Gam Industries, Inc.
General Hospital · 91d
Cleared Dec 31, 1991
CHEM-SLEEVE B
K912257
Haz-Med, Inc.
General Hospital · 223d
Cleared May 28, 1991
MEDI GUARD PILLOWCASE
K911948
Sancella, Inc.
General Hospital · 27d
Cleared May 28, 1991
MEDI GUARD UNDERPAD
K911952
Sancella, Inc.
General Hospital · 27d
Cleared May 28, 1991
MEDI GUARD SHEETS/UNDERLAYS
K911953
Sancella, Inc.
General Hospital · 27d
Cleared May 21, 1991
MEDI GUARD DRAPES
K911950
Sancella, Inc.
General Hospital · 20d
Cleared Dec 28, 1990
BIO-GUARD SHAVE PREP TRAY
K905003
Network Medical Systems, Inc.
General Hospital · 51d
Cleared Oct 26, 1990
RECEIVING BLANKET
K904274
Anago, Inc.
General Hospital · 38d
Cleared Sep 12, 1990
TRAUMA SLEEVE
K901509
Haz-Med, Inc.
General Hospital · 166d
Cleared Apr 27, 1990
CHEM-SLEEVE
K901629
Haz-Med, Inc.
General Hospital · 28d
Cleared Apr 25, 1990
FLUID SOAKERSHIELD
K900643
Infection Control Products, Inc.
General Hospital · 75d
Cleared Jan 10, 1990
MATTRESS COVER FOR MEDICAL PURPOSES
K896043
Keystone Veterinary Supplies, Inc.
General Hospital · 86d
Cleared Dec 29, 1989
MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
K891986
Mark One Healthcare Products
General Hospital · 276d
Cleared Sep 07, 1989
DEVON DISPOSABLE HEAD POSITIONER COVER
K894170
Devon Industries, Inc.
General Hospital · 84d
Cleared Nov 08, 1988
BED SHEET, PILLOW CASE
K884380
Saybrex Intl., Inc.
General Hospital · 21d
Cleared Jul 19, 1988
HEADREST, PATIENT COMFORT
K882332
Surgic Aid, Inc.
General Hospital · 43d
Cleared Jun 07, 1988
DRY COMFORT DISPOSABLE UNDERPAD
K881969
Health Tec, Inc.
General Hospital · 27d
Cleared Jun 03, 1988
DRIPRIDE DISPOSABLE UNDERPAD
K881859
Weyerhaeuser Co.
General Hospital · 31d
Cleared May 15, 1987
DRIPRIDE DISPOSABLE UNDERPADS
K871725
Weyerhaeuser Co.
General Hospital · 11d

About Product Code KME - Regulatory Context