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

Cleared Dec 22, 2010

RESTORELLE POLYPROPYLENE MESH

K103568 · FTL

General & Plastic Surgery · 16d

Cleared Oct 18, 2010

RE-TRACE URETERAL ACCESS SHEATH

K102485 · FED

Gastroenterology & Urology · 49d

Cleared Jun 03, 2010

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020

K101297 · OTM

Gastroenterology & Urology · 24d

Cleared Feb 17, 2010

BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

K100218 · FRO

General & Plastic Surgery · 22d

Cleared Nov 23, 2009

COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM

K083770 · KNT

Gastroenterology & Urology · 340d

Cleared May 08, 2009

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS

K083499 · OTP

Obstetrics & Gynecology · 164d

Cleared May 07, 2009

VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020

K091152 · OTM

Gastroenterology & Urology · 17d

Cleared Apr 23, 2009

BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070

K090217 · FBK

Gastroenterology & Urology · 84d

Cleared Sep 29, 1995

COMFEEL:ALGINATE DRESSING

K953497 · KMF

General & Plastic Surgery · 65d

Cleared Feb 13, 1995

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER

K946243 · EXJ

Gastroenterology & Urology · 53d

Cleared Mar 16, 1993

COMFEEL(R) WOUND DRESSING SD

K925376 · KMF

General & Plastic Surgery · 144d

Cleared Oct 30, 1992

CONVEEN(R) LEG BAG(500 ML)

K924406 · FAQ

Gastroenterology & Urology · 66d

Cleared Sep 23, 1992

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH

K924407 · EXJ

Gastroenterology & Urology · 29d

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 Feb 05, 1992

CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)

K915246 · EXI

Gastroenterology & Urology · 82d

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 Feb 09, 1990

CONVEEN INTERMITTENT CATHETERS

K895548 · KOD

Gastroenterology & Urology · 149d

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 Jul 13, 1988

CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)

K881636 · EXB

Gastroenterology & Urology · 90d

Cleared Nov 17, 1987

COMFEEL ULCUS ULCER CARE SYSTEM

K873669 · FRO

General & Plastic Surgery · 67d

Cleared Jun 10, 1987

CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)

K871610 · KNX

Gastroenterology & Urology · 47d