Coloplast Corp. - FDA 510(k) Cleared Devices

Cleared Aug 02, 2013

RESTORELLE M, RESTORELLE XL

K132061 · OTO

Obstetrics & Gynecology · 30d

Cleared Dec 18, 2012

NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015

K122968 · OTO

Obstetrics & Gynecology · 84d

Cleared Nov 19, 2012

RESTORELLE L

K122440 · OTO

Obstetrics & Gynecology · 101d

Cleared Oct 02, 2012

SPEEDICATH COMPACT SET (12 FR)

K121457 · GBM

Gastroenterology & Urology · 139d

Cleared Sep 08, 2011

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

K112386 · OTP

Obstetrics & Gynecology · 21d

Cleared Nov 09, 2007

SPEEDICATH COMPACT

K072808 · GBM

Gastroenterology & Urology · 39d

Cleared Oct 13, 2006

COLOPLAST OSTOMY ROD, MODEL 12814

K052229 · EZP

Gastroenterology & Urology · 423d

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 Jan 27, 2003

SPEEDICATH

K023254 · GBM

Gastroenterology & Urology · 119d

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 Nov 06, 1997

CONVEEN EASICATH SET

K973070 · EZD

Gastroenterology & Urology · 80d

Cleared Jul 29, 1997

COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)

K971597 · NAE

General & Plastic Surgery · 89d

Cleared Dec 29, 1995

CONVEEN URINE BAG - STERILE

K955609 · FAQ

Gastroenterology & Urology · 21d

Cleared Nov 14, 1995

COMFEEL:ALGINATE FILLER

K954857 · KMF

General & Plastic Surgery · 22d

Cleared Sep 13, 1995

CONVEEN LEG BAG STRAP

K953783 · FAQ

Gastroenterology & Urology · 30d

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