Medical Device Manufacturer · US , Mchenry , IL

Coloplast A/S - FDA 510(k) Cleared Devices

71 submissions · 68 cleared · Since 1983
71
Total
68
Cleared
0
Denied

FDA 510(k) cleared devices by Coloplast A/S General & Plastic Surgery

19 devices
1-19 of 19
Cleared Feb 21, 2020
Biatain Silicone Ag
K191536 · FRO
General & Plastic Surgery · 256d
Cleared May 23, 2012
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0,...
K120284 · NEW
General & Plastic Surgery · 113d
Cleared Apr 05, 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5...
K120828 · FRO
General & Plastic Surgery · 17d
Cleared Dec 22, 2010
RESTORELLE POLYPROPYLENE MESH
K103568 · FTL
General & Plastic Surgery · 16d
Cleared Feb 17, 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218 · FRO
General & Plastic Surgery · 22d
Cleared Sep 29, 1995
COMFEEL:ALGINATE DRESSING
K953497 · KMF
General & Plastic Surgery · 65d
Cleared Mar 16, 1993
COMFEEL(R) WOUND DRESSING SD
K925376 · KMF
General & Plastic Surgery · 144d
Cleared Aug 17, 1992
COMFEEL WOUND DRESSING ORD
K922461 · KMF
General & Plastic Surgery · 83d
Cleared Aug 17, 1992
COMFEEL WOUND DRESSING SD
K922466 · KMF
General & Plastic Surgery · 83d
Cleared May 28, 1992
COMFEEL CONTOUR DRESSING
K920925 · KMF
General & Plastic Surgery · 90d
Cleared Oct 31, 1990
ELLA BREAST FORM
K904085 · KCZ
General & Plastic Surgery · 56d
Cleared Oct 02, 1990
DISCRENE SELF-SUPPORTING BREAST FORM
K904086 · KCZ
General & Plastic Surgery · 27d
Cleared Sep 26, 1989
COMFEEL TRANSPARENT DRESSING
K894916 · KGX
General & Plastic Surgery · 55d
Cleared Sep 22, 1988
COMPEED ATHLETIC DRESSING
K883588 · FRO
General & Plastic Surgery · 31d
Cleared Nov 17, 1987
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · FRO
General & Plastic Surgery · 67d
Cleared Nov 08, 1984
COMFEEL POWDER
K834343 · KOZ
General & Plastic Surgery · 332d
Cleared Nov 07, 1984
COMFEEL PASTE
K840362
General & Plastic Surgery · 286d
Cleared Nov 07, 1984
COMFEEL ULCUS SHEET
K840438 · FRO
General & Plastic Surgery · 280d
Cleared Dec 12, 1983
COMFEEL PROTECTIVE RINGS
K832908 · EYF
General & Plastic Surgery · 105d
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