Coloplast A S

FDA Filings

This page includes the latest FDA filings for Coloplast A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

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COLO B

DUNS 305524696

FDA Filings

Device Company	Device	Date
PMN K220420 Coloplast A/S	Saffron Fixation System	2022-06-10
GUDID 05708932500968 Coloplast A/S	Brava 120215	2022-05-16
GUDID 05708932408707 Coloplast A/S	SenSura Click 10045	2022-05-16
GUDID 05708932408684 Coloplast A/S	SenSura Click 10036	2022-05-16
GUDID 05708932408646 Coloplast A/S	SenSura Click 10027	2022-05-16
GUDID 05708932408622 Coloplast A/S	SenSura Click 10026	2022-05-16
GUDID 05708932408585 Coloplast A/S	SenSura Click 10017	2022-05-16
GUDID 05708932408561 Coloplast A/S	SenSura Click 10016	2022-05-16
GUDID 05708932403511 Coloplast A/S	SenSura Click 10041	2022-05-16
GUDID 05708932377737 Coloplast A/S	SenSura Click 10032	2022-05-16
GUDID 05708932377515 Coloplast A/S	SenSura Click 10023	2022-05-16
GUDID 05708932377492 Coloplast A/S	SenSura Click 10022	2022-05-16
GUDID 05708932377478 Coloplast A/S	SenSura Click 10013	2022-05-16
GUDID 05708932377263 Coloplast A/S	SenSura Click 10012	2022-05-16
GUDID 00762123054024 Coloplast A/S	SenSura Click 10023	2022-05-16
GUDID 00762123033975 Coloplast A/S	Assura 12134	2022-05-16
GUDID 00762123033937 Coloplast A/S	Assura 12130	2022-05-16
GUDID 00762123033623 Coloplast A/S	Assura 12110	2022-05-16
GUDID 00762123001493 Coloplast A/S	Coloplast 9500	2022-05-03
GUDID 00311701161564 Coloplast A/S	WOUN'DRES 7690	2022-05-02
GUDID 00311701161526 Coloplast A/S	WOUN'DRES 1166	2022-05-02
GUDID 00311701159561 Coloplast A/S	SEA-CLENS 1063	2022-05-02
GUDID 00311701159554 Coloplast A/S	Sea-Clens 1061	2022-05-02
GUDID 00311701031522 Coloplast A/S	TRIAD 1967	2022-05-02
GUDID 00311701031430 Coloplast A/S	TRIAD 1964	2022-05-02
GUDID 00311701007930 Coloplast A/S	COLOPLAST PREP 0925	2022-05-02
GUDID 05708932721974 Coloplast A/S	Brava 12033	2022-04-18
GUDID 05708932721776 Coloplast A/S	Brava 12032	2022-04-18
GUDID 05708932676663 Coloplast A/S	Brava 12076	2022-04-18
GUDID 05708932574426 Coloplast A/S	Brava 120740	2022-04-18
GUDID 05708932574419 Coloplast A/S	Brava 120721	2022-04-18
GUDID 05708932507318 Coloplast A/S	Brava 120700	2022-04-18
GUDID 05708932501484 Coloplast A/S	Brava 32205	2022-04-18
GUDID 05708932501477 Coloplast A/S	Brava 32155	2022-04-18
GUDID 05708932501453 Coloplast A/S	Brava 32105	2022-04-18
GUDID 05708932500692 Coloplast A/S	Brava 26555	2022-04-18
GUDID 05708932477956 Coloplast A/S	Coloplast 02650	2022-04-18
GUDID 05708932410229 Coloplast A/S	Brava 12046	2022-04-18
GUDID 05708932410212 Coloplast A/S	Brava 12048	2022-04-18
GUDID 05708932410205 Coloplast A/S	Brava 12038	2022-04-18
GUDID 05708932409452 Coloplast A/S	Brava 12036	2022-04-18
GUDID 05708932016254 Coloplast A/S	Brava 12049	2022-04-18
GUDID 05708932016223 Coloplast A/S	Brava 12039	2022-04-18
GUDID 05708932016216 Coloplast A/S	Brava 12037	2022-04-18
GUDID 05708932016148 Coloplast A/S	Brava 12047	2022-04-18
GUDID 05708932016131 Coloplast A/S	Brava 12045	2022-04-18
GUDID 05708932016100 Coloplast A/S	Brava 12035	2022-04-18
GUDID 00762123006894 Coloplast A/S	Coloplast 2350	2022-04-18
GUDID 00762123006887 Coloplast A/S	Coloplast 2340	2022-04-18
GUDID 00762123006870 Coloplast A/S	Coloplast 2330	2022-04-18
GUDID 00762123006863 Coloplast A/S	Coloplast 2325	2022-04-18
GUDID 00762123006856 Coloplast A/S	Coloplast 2320	2022-04-18
GUDID 00762123006849 Coloplast A/S	Coloplast 2315	2022-04-18
GUDID 00762123006832 Coloplast A/S	Coloplast 2310	2022-04-18
GUDID 05708932698337 Coloplast A/S	SpeediCath 28702	2022-04-11
GUDID 05708932641623 Coloplast A/S	Comfeel Plus Transparent 33536	2022-03-21
GUDID 05708932641609 Coloplast A/S	Comfeel Plus Transparent 33533	2022-03-21
GUDID 05708932641579 Coloplast A/S	Comfeel Plus Transparent 33530	2022-03-21
GUDID 05708932641531 Coloplast A/S	Comfeel Plus 33285	2022-03-21
GUDID 05708932641517 Coloplast A/S	Comfeel Plus Contour 33283	2022-03-21
GUDID 05708932641470 Coloplast A/S	Comfeel Plus Contour 33280	2022-03-21
GUDID 05708932641449 Coloplast A/S	Comfeel Plus 33146	2022-03-21
GUDID 05708932641425 Coloplast A/S	Comfeel Plus 33120	2022-03-21
GUDID 05708932641388 Coloplast A/S	Comfeel Plus 33115	2022-03-21
GUDID 05708932641364 Coloplast A/S	Comfeel Plus 33110	2022-03-21
GUDID 05708932539395 Coloplast A/S	Conveen Security+ 21054	2022-03-21
GUDID 05708932539371 Coloplast A/S	Conveen Security+ 21053	2022-03-21
GUDID 05708932539333 Coloplast A/S	Conveen Security+ 21034	2022-03-21
GUDID 05708932539302 Coloplast A/S	Conveen Security+ 21029	2022-03-21
GUDID 05708932539289 Coloplast A/S	Conveen Security+ 21027	2022-03-21
GUDID 05708932539258 Coloplast A/S	Conveen Security+ 21026	2022-03-21
GUDID 05708932505567 Coloplast A/S	Conveen Active 25502	2022-03-21
GUDID 05708932504232 Coloplast A/S	Brava 004220	2022-03-21
GUDID 05708932504218 Coloplast A/S	Brava 4215	2022-03-21
GUDID 05708932015097 Coloplast A/S	Comfeel Plus Transparent 33539	2022-03-21
GUDID 00762123051085 Coloplast A/S	Coloplast 14010	2022-03-21
GUDID 00762123051009 Coloplast A/S	Coloplast 14021	2022-03-21
GUDID 00762123049587 Coloplast A/S	Coloplast 14031	2022-03-21
GUDID 00762123049556 Coloplast A/S	Coloplast 14041	2022-03-21
GUDID 00762123049518 Coloplast A/S	Coloplast 14015	2022-03-21
GUDID 00762123049495 Coloplast A/S	Coloplast 14070	2022-03-21
GUDID 00762123049471 Coloplast A/S	Coloplast 14050	2022-03-21
GUDID 00762123049464 Coloplast A/S	Coloplast 14060	2022-03-21
GUDID 00762123049440 Coloplast A/S	Coloplast 14010	2022-03-21
GUDID 00762123046814 Coloplast A/S	Conveen Security+ 21346	2022-03-21
GUDID 00762123034224 Coloplast A/S	Alterna 12174	2022-03-21
GUDID 00762123034095 Coloplast A/S	Assura 12149	2022-03-21
GUDID 00762123034071 Coloplast A/S	Assura 12146	2022-03-21
GUDID 00762123034064 Coloplast A/S	Assura 12145	2022-03-21
GUDID 00762123034057 Coloplast A/S	Assura 12144	2022-03-21
GUDID 00762123034040 Coloplast A/S	Alterna 12177	2022-03-21
GUDID 00762123034033 Coloplast A/S	Alterna 12176	2022-03-21
GUDID 00762123034026 Coloplast A/S	Alterna 12175	2022-03-21
GUDID 00762123034019 Coloplast A/S	Assura 12147	2022-03-21
GUDID 00762123033999 Coloplast A/S	Assura 12136	2022-03-21
GUDID 00762123033982 Coloplast A/S	Assura 12135	2022-03-21
GUDID 00762123033968 Coloplast A/S	Alterna 12170	2022-03-21
GUDID 00762123033944 Coloplast A/S	Assura 12140	2022-03-21
GUDID 00762123002179 Coloplast A/S	Conveen Contour 05174	2022-03-21
GUDID 00762123002148 Coloplast A/S	Conveen Contour 05170	2022-03-21
GUDID 00762123002056 Coloplast A/S	Conveen Contour 5171	2022-03-21
PMN K191536 Coloplast A/S	Biatain Silicone Ag	2020-02-21
PMN K181811 Coloplast A/S	ReTrace Ureteral Access Sheath	2018-09-07
PMN K173527 Coloplast A/S	Digitex Delivery Device	2018-02-12
PMN K140310 COLOPLAST A/S	Peristeen Anal Irrigation System	2015-09-03
PMN K150935 COLOPLAST A/S	SpeediCath Compact Eve	2015-07-02
PMN K150927 COLOPLAST A/S	Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic Guidewire Angled Stiff,Orchestra Hydrophilic Guidewire Standard Straight, Orchestra Hydrophilic Guidewire Straight Stiff	2015-05-27
PMN K143182 COLOPLAST A/S	Speedicath Compact Male	2015-01-20
PMN K140523 COLOPLAST A/S	RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM	2014-07-24
PMN K140116 COLOPLAST A/S	RESTORELLE Y CONTOUR MESH	2014-02-12
PMN K131072 COLOPLAST A/S	ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC	2013-07-09
PMN K123914 COLOPLAST A/S	RESTORELLE Y CONTOUR	2013-03-05
PMN K123675 COLOPLAST A/S	RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR	2013-03-01
PMN K121562 COLOPLAST A/S	ALTIS SINGLE INCISION CLING SYSTEM	2012-11-05
PMN K121458 COLOPLAST A/S	SPEEDICATH COMPACT SET (12/18 FR)	2012-10-01
PMN K121833 COLOPLAST A/S	OSTOMY IRRIGATION SET	2012-07-16
PMN K112860 COLOPLAST A/S	PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER	2012-06-08
PMN K120284 COLOPLAST A/S	DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX	2012-05-23
PMN K112322 COLOPLAST A/S	RESTORELLE POLYPROPYLENE Y MESH	2012-05-17
PMN K120828 COLOPLAST A/S	BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES	2012-04-05
PMN K113496 COLOPLAST A/S	VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT	2012-02-14
PMN K111881 COLOPLAST A/S	VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT	2011-08-17
PMN K111233 COLOPLAST A/S	SUPRIS RETROPUBIC SLING SYSTEM	2011-06-24
PMN K103254 COLOPLAST A/S	PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE	2011-01-31
PMN K103568 COLOPLAST A/S	RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH	2010-12-22
PMN K102485 COLOPLAST A/S	RE-TRACE URETERAL ACCESS SHEATH	2010-10-18
PMN K101297 COLOPLAST A/S	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020	2010-06-03
PMN K100218 COLOPLAST A/S	BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM	2010-02-17
PMN K083770 COLOPLAST A/S	COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM	2009-11-23
PMN K083499 COLOPLAST A/S	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS	2009-05-08
PMN K091152 COLOPLAST A/S	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020	2009-05-07
PMN K090217 COLOPLAST A/S	BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070	2009-04-23
PMN K953497 COLOPLAST A/S	COMFEEL:ALGINATE DRESSING	1995-09-29
PMN K946243 COLOPLAST A/S	CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER	1995-02-13
PMN K925376 COLOPLAST A/S	COMFEEL(R) WOUND DRESSING SD	1993-03-16
PMN K924406 COLOPLAST A/S	CONVEEN(R) LEG BAG(500 ML)	1992-10-30
PMN K924407 COLOPLAST A/S	CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH	1992-09-23
PMN K922466 COLOPLAST A/S	COMFEEL WOUND DRESSING SD	1992-08-17
PMN K922461 COLOPLAST A/S	COMFEEL WOUND DRESSING ORD	1992-08-17
PMN K920925 COLOPLAST A/S	COMFEEL CONTOUR DRESSING	1992-05-28
PMN K915246 COLOPLAST A/S	CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)	1992-02-05
PMN K904085 COLOPLAST A/S	ELLA BREAST FORM	1990-10-31
PMN K904086 COLOPLAST A/S	DISCRENE SELF-SUPPORTING BREAST FORM	1990-10-02
PMN K895548 COLOPLAST A/S	CONVEEN INTERMITTENT CATHETERS	1990-02-09
PMN K894916 COLOPLAST A/S	COMFEEL TRANSPARENT DRESSING	1989-09-26
PMN K883588 COLOPLAST A/S	COMPEED ATHLETIC DRESSING	1988-09-22
PMN K881636 COLOPLAST A/S	CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)	1988-07-13
PMN K873669 COLOPLAST A/S	COMFEEL ULCUS ULCER CARE SYSTEM	1987-11-17
PMN K871643 COLOPLAST A/S	CONVEEN(R) LEG-BAG (600 ML)	1987-06-10
PMN K871610 COLOPLAST A/S	CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)	1987-06-10
PMN K863830 COLOPLAST A/S	CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM	1986-10-16
PMN K861070 COLOPLAST A/S	COLOPLAST CONVEX RING	1986-06-16
PMN K854580 COLOPLAST A/S	CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH	1985-12-13
PMN K844685 COLOPLAST A/S	COLOPLAST URO 2002 UROSTOMY SYSTEM	1985-01-08
PMN K844684 COLOPLAST A/S	COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM	1985-01-08
PMN K834343 COLOPLAST A/S	COMFEEL POWDER	1984-11-08
PMN K840438 COLOPLAST A/S	COMFEEL ULCUS SHEET	1984-11-07
PMN K840362 COLOPLAST A/S	COMFEEL PASTE	1984-11-07
PMN K833567 COLOPLAST A/S	COMFEEL PROTECTIVE FILM	1984-05-02
PMN K840268 COLOPLAST A/S	IRRIGATION SYSTEM	1984-04-05
PMN K840269 COLOPLAST A/S	MC 2000 OSTOMY POUCHES	1984-04-02
PMN K840267 COLOPLAST A/S	FILTRODER FILTERS	1984-04-02
PMN K840265 COLOPLAST A/S	MC 2002 OSTOMY POUCHES & SKIN FLANGES	1984-04-02
PMN K833571 COLOPLAST A/S	STERILE DRAINAGE SYSTEM	1984-01-30
PMN K833570 COLOPLAST A/S	COLOPLAST BABY URINE COLLECTORS	1984-01-30
PMN K833565 COLOPLAST A/S	COMFEEL PASTE	1984-01-30
PMN K840266 COLOPLAST A/S	K-FLEX OSTOMY POUCH	1984-01-23
PMN K833569 COLOPLAST A/S	COMFEEL BARRIER CREAM	1983-12-27
PMN K833566 COLOPLAST A/S	COMFEEL CLEANSER	1983-12-27
PMN K832908 COLOPLAST A/S	COMFEEL PROTECTIVE RINGS	1983-12-12

Similar & Related FDA Registered Companies

• COLOPLAST MANUFACTURING US, LLC
• COLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP000006 Supplement NumberS061 Date Received03/16/2022 Decision Date04/15/2022 Product Code FHW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	R3199	COLOPLAST A/S
CAGE Code	R3199	COLOPLAST A/S
SEC	0001294323	COLOPLAST A/S
SEC	0001294325	COLOPLAST A/S

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929102255	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	TAPE AND BANDAGES ON 40 PALLET S REF: 376771 + 376772 INVO ICE NO: 19063906 / RI; 1906390 7 / RI JNJ PO NO: 451530977, 451530983 CONTRACT NO: US036- 11 NET: 2833,068,- KG HS COD E: 3005.10.00 SEAL : MBX09825	5039 PKG
2020092839885	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	25 PKG
2020092856409	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG
2020092841426	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG
2020092847799	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	1764 PKG
2020092847799	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	1764 PKG
2020092858120	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG
2020092842168	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG
2020092841488	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	MEDICAL SUPPLIES	31 PKG