Medical Device Manufacturer · US , Marietta , GA

Coloplast Corp. - FDA 510(k) Cleared Devices

54 submissions · 47 cleared · Since 1985
54
Total
47
Cleared
0
Denied

FDA 510(k) cleared devices by Coloplast Corp. General & Plastic Surgery

20 devices
1-20 of 20
Cleared Mar 22, 2024
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in)
K231953 · FRO
General & Plastic Surgery · 266d
Cleared Dec 10, 2018
SabreLine and SabreGuard Laser Fibers
K182831 · GEX
General & Plastic Surgery · 62d
Cleared May 17, 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869 · FRO
General & Plastic Surgery · 157d
Cleared Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · FRO
General & Plastic Surgery · 194d
Cleared Oct 04, 2002
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X...
K013525 · MGQ
General & Plastic Surgery · 346d
Cleared Jun 04, 1999
MODIFICATION TO WOUN'DRES
K991202 · MGQ
General & Plastic Surgery · 74d
Cleared Jan 28, 1999
COMPEED PSORIASIS DRESSING
K982493 · FRO
General & Plastic Surgery · 195d
Cleared Dec 30, 1998
COMFEEL SEASORB DRESSING
K983519 · KMF
General & Plastic Surgery · 83d
Cleared Dec 16, 1998
BIATAIN FOAM DRESSING
K983163 · FRO
General & Plastic Surgery · 97d
Cleared Dec 16, 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173 · FRO
General & Plastic Surgery · 97d
Cleared Nov 25, 1998
SWEEN WOUN'DRES
K983042 · MGQ
General & Plastic Surgery · 86d
Cleared Jul 29, 1997
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
K971597 · NAE
General & Plastic Surgery · 89d
Cleared Nov 14, 1995
COMFEEL:ALGINATE FILLER
K954857 · KMF
General & Plastic Surgery · 22d
Cleared Sep 14, 1992
SKIN SUPPORT PREP PAD
K923351 · KOX
General & Plastic Surgery · 68d
Cleared May 11, 1992
SUOENA AFFINITY (TM) MODEL #802
K921535 · KCZ
General & Plastic Surgery · 41d
Cleared Jan 14, 1992
AMOENA AFFINITY MODEL #802
K915382 · KCZ
General & Plastic Surgery · 46d
Cleared Oct 11, 1990
NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
K904316 · KCZ
General & Plastic Surgery · 20d
Cleared Jan 08, 1987
AMOENA BREAST FORMS
K864785 · GBI
General & Plastic Surgery · 31d
Cleared Jan 08, 1987
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
K864786 · GBI
General & Plastic Surgery · 31d
Cleared Sep 30, 1985
AMOENA BREAST FORMS
K853822 · GBI
General & Plastic Surgery · 17d
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