KDD · Class I · 21 CFR 878.4800

FDA Product Code KDD: Kit, Surgical Instrument, Disposable

Leading manufacturers include Pro-Pak, Ulti-Med Intl., Inc. and American Medical Disposable, Inc..

62
Total
62
Cleared
87d
Avg days
1976
Since
62 devices
25–48 of 62
Cleared Mar 20, 1987
STERILE PROCEDURAL TRAYS
K870373
Dimed, Intl.
General & Plastic Surgery · 50d
Cleared Feb 18, 1987
JMS HALO APPLICATION TRAY
K864969
Jerome Medical
General & Plastic Surgery · 58d
Cleared Oct 08, 1985
SUTURE REMOVAL KIT
K853910
Scientific & Medical Care Co.
General & Plastic Surgery · 18d
Cleared May 24, 1985
COOK COUNTY HOSPITAL DRESSING CHANGE SET
K843206
Geneva Laboratories, Inc.
General & Plastic Surgery · 282d
Cleared Feb 26, 1985
STERILE SUTURE REMOVAL KIT
K850325
Excel Health Care Products
General & Plastic Surgery · 29d
Cleared Sep 26, 1984
C-SECTION TRAY
K842627
Deroyal Industries, Inc.
General & Plastic Surgery · 82d
Cleared Sep 07, 1984
STERILE SOLUTION BOWL
K843115
E.M. Adams
Neurology · 30d
Cleared Apr 27, 1984
STERILE SUTURE BOOTS
K834135
Devon Industries, Inc.
General & Plastic Surgery · 148d
Cleared Feb 09, 1984
PREPACELL-STERILE-BONE MARROW ASPIR
K833438
Applied Medical Devices, Inc.
General & Plastic Surgery · 127d
Cleared Jan 30, 1984
VYGON THORACIC DRAINAGE-VARIOUS #'S
K832628
Exco, Inc.
General & Plastic Surgery · 179d
Cleared Jan 27, 1984
WET DRESSING KIT
K833075
Clinipad Corp.
General & Plastic Surgery · 140d
Cleared Jan 25, 1984
STERILE WET DRESSING PACK
K834532
W.G. Whitney Corp.
General & Plastic Surgery · 35d
Cleared Dec 14, 1983
STERILE DISP. INSTRUMENT TRAYS
K831841
E.M. Adams
General & Plastic Surgery · 190d
Cleared Sep 12, 1983
STERILE SUTURE REMOVAL SET
K832047
Ormed Mfg., Inc.
General & Plastic Surgery · 80d
Cleared Sep 01, 1983
FIRST AID KITS
K831795
I M, Inc.
General & Plastic Surgery · 90d
Cleared May 13, 1983
RESCUE PACK
K830374
Akla, Inc.
General & Plastic Surgery · 98d
Cleared Oct 13, 1982
OPEN HEART TRAY (CUSTOM DESIGNED)
K822158
Megaplast, Inc.
General & Plastic Surgery · 82d
Cleared Jul 09, 1982
STERILE SUTURE REMOVAL KIT
K821502
Pro-Pak
General & Plastic Surgery · 51d
Cleared Jul 09, 1982
HEMO-NATE L-P KIT
K821814
Int'L Corp.
General & Plastic Surgery · 21d
Cleared Jun 23, 1982
STERILE CATH CARE KIT
K821500
Pro-Pak
General & Plastic Surgery · 35d
Cleared Jun 16, 1982
STERILE TRACHEOSTOMY CARE KIT
K821501
Pro-Pak
General & Plastic Surgery · 28d
Cleared Mar 10, 1982
SUTURE REMOVAL TRAY
K820423
Megaplast, Inc.
General & Plastic Surgery · 22d
Cleared Dec 09, 1981
ACKRAD INCISION & DRAIN SET
K813103
Ackrad Laboratories
General & Plastic Surgery · 36d
Cleared Jul 31, 1981
SKIN SCRUB KITS
K811855
Oem Medical Div.
General & Plastic Surgery · 30d