Atlas FDA

Coloplast A.S.

72 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Luja Soft (K262045)Coloplast A.S.2026-07-07
Altis Single Incision Sling System (K221874)Coloplast A/S2023-02-15
Saffron Fixation System (K220420)Coloplast A/S2022-06-10
Biatain Silicone Ag (K191536)Coloplast A/S2020-02-21
ReTrace Ureteral Access Sheath (K181811)Coloplast A/S2018-09-07
Digitex Delivery Device (K173527)Coloplast A/S2018-02-12
Peristeen Anal Irrigation System (K140310)Coloplast A/S2015-09-03
SpeediCath Compact Eve (K150935)Coloplast A/S2015-07-02
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 (K150927)Coloplast A/S2015-05-27
Speedicath Compact Male (K143182)Coloplast A/S2015-01-20
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM (K140523)Coloplast A/S2014-07-24
RESTORELLE Y CONTOUR MESH (K140116)Coloplast A/S2014-02-12
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC (K131072)Coloplast A/S2013-07-09
RESTORELLE Y CONTOUR (K123914)Coloplast A/S2013-03-05
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR (K123675)Coloplast A/S2013-03-01
ALTIS SINGLE INCISION CLING SYSTEM (K121562)Coloplast A/S2012-11-05
SPEEDICATH COMPACT SET (12/18 FR) (K121458)Coloplast A/S2012-10-01
OSTOMY IRRIGATION SET (K121833)Coloplast A/S2012-07-16
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER (K112860)Coloplast A/S2012-06-08
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX (K120284)Coloplast A/S2012-05-23
RESTORELLE POLYPROPYLENE Y MESH (K112322)Coloplast A/S2012-05-17
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES (K120828)Coloplast A/S2012-04-05
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT (K113496)Coloplast A/S2012-02-14
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT (K111881)Coloplast A/S2011-08-17
SUPRIS RETROPUBIC SLING SYSTEM (K111233)Coloplast A/S2011-06-24
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE (K103254)Coloplast A/S2011-01-31
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH (K103568)Coloplast A/S2010-12-22
RE-TRACE URETERAL ACCESS SHEATH (K102485)Coloplast A/S2010-10-18
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 (K101297)Coloplast A/S2010-06-03
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM (K100218)Coloplast A/S2010-02-17
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM (K083770)Coloplast A/S2009-11-23
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (K083499)Coloplast A/S2009-05-08
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (K091152)Coloplast A/S2009-05-07
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 (K090217)Coloplast A/S2009-04-23
COMFEEL:ALGINATE DRESSING (K953497)Coloplast A/S1995-09-29
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER (K946243)Coloplast A/S1995-02-13
COMFEEL(R) WOUND DRESSING SD (K925376)Coloplast A/S1993-03-16
CONVEEN(R) LEG BAG(500 ML) (K924406)Coloplast A/S1992-10-30
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH (K924407)Coloplast A/S1992-09-23
COMFEEL WOUND DRESSING SD (K922466)Coloplast A/S1992-08-17
COMFEEL WOUND DRESSING ORD (K922461)Coloplast A/S1992-08-17
COMFEEL CONTOUR DRESSING (K920925)Coloplast A/S1992-05-28
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) (K915246)Coloplast A/S1992-02-05
ELLA BREAST FORM (K904085)Coloplast A/S1990-10-31
DISCRENE SELF-SUPPORTING BREAST FORM (K904086)Coloplast A/S1990-10-02
CONVEEN INTERMITTENT CATHETERS (K895548)Coloplast A/S1990-02-09
COMFEEL TRANSPARENT DRESSING (K894916)Coloplast A/S1989-09-26
COMPEED ATHLETIC DRESSING (K883588)Coloplast A/S1988-09-22
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (K881636)Coloplast A/S1988-07-13
COMFEEL ULCUS ULCER CARE SYSTEM (K873669)Coloplast A/S1987-11-17
CONVEEN(R) LEG-BAG (600 ML) (K871643)Coloplast A/S1987-06-10
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML) (K871610)Coloplast A/S1987-06-10
CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM (K863830)Coloplast A/S1986-10-16
COLOPLAST CONVEX RING (K861070)Coloplast A/S1986-06-16
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH (K854580)Coloplast A/S1985-12-13
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM (K844684)Coloplast A/S1985-01-08
COLOPLAST URO 2002 UROSTOMY SYSTEM (K844685)Coloplast A/S1985-01-08
COMFEEL POWDER (K834343)Coloplast A/S1984-11-08
COMFEEL ULCUS SHEET (K840438)Coloplast A/S1984-11-07
COMFEEL PASTE (K840362)Coloplast A/S1984-11-07
COMFEEL PROTECTIVE FILM (K833567)Coloplast A/S1984-05-02
IRRIGATION SYSTEM (K840268)Coloplast A/S1984-04-05
MC 2000 OSTOMY POUCHES (K840269)Coloplast A/S1984-04-02
FILTRODER FILTERS (K840267)Coloplast A/S1984-04-02
MC 2002 OSTOMY POUCHES & SKIN FLANGES (K840265)Coloplast A/S1984-04-02
COMFEEL PASTE (K833565)Coloplast A/S1984-01-30
COLOPLAST BABY URINE COLLECTORS (K833570)Coloplast A/S1984-01-30
STERILE DRAINAGE SYSTEM (K833571)Coloplast A/S1984-01-30
K-FLEX OSTOMY POUCH (K840266)Coloplast A/S1984-01-23
COMFEEL CLEANSER (K833566)Coloplast A/S1983-12-27
COMFEEL BARRIER CREAM (K833569)Coloplast A/S1983-12-27
COMFEEL PROTECTIVE RINGS (K832908)Coloplast A/S1983-12-12

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Every clearance here is in the API, with alerts when new ones post.