Coloplast A.S.

FDA 510(k) & PMA Approved Devices — 66 products

Total Devices66

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K262045	Luja Soft	EZD	2026-07-07	View
510(k)	K221874	Altis Single Incision Sling System	PAH	2023-02-15	View
510(k)	K220420	Saffron Fixation System	PBQ	2022-06-10	View
510(k)	K191536	Biatain Silicone Ag	FRO	2020-02-21	View
510(k)	K181811	ReTrace Ureteral Access Sheath	FED	2018-09-07	View
510(k)	K173527	Digitex Delivery Device	PWI	2018-02-12	View
510(k)	K131072	ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC	OCY	2013-07-09	View
510(k)	K123914	RESTORELLE Y CONTOUR	OTO	2013-03-05	View
510(k)	K123675	RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR	FED	2013-03-01	View
510(k)	K121562	ALTIS SINGLE INCISION CLING SYSTEM	PAH	2012-11-05	View
510(k)	K121458	SPEEDICATH COMPACT SET (12/18 FR)	GBM	2012-10-01	View
510(k)	K121833	OSTOMY IRRIGATION SET	EXD	2012-07-16	View
510(k)	K112860	PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER	KNT	2012-06-08	View
510(k)	K120284	DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX	NEW	2012-05-23	View
510(k)	K112322	RESTORELLE POLYPROPYLENE Y MESH	OTO	2012-05-17	View
510(k)	K120828	BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES	FRO	2012-04-05	View
510(k)	K113496	VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT	OTM	2012-02-14	View
510(k)	K111881	VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT	OTM	2011-08-17	View
510(k)	K111233	SUPRIS RETROPUBIC SLING SYSTEM	OTN	2011-06-24	View
510(k)	K103254	PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE	KNT	2011-01-31	View