FDA.reportPublic FDA data

COLOPLAST MANUFACTURING US, LLC

Matched from indexed company URL: Coloplast Manufacturing US LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21250502125050COLOPLAST MANUFACTURING US, LLC1Y2026-01-011601 W River Rd N MINNEAPOLIS MN US 55411
30300876933030087693Coloplast Manufacturing US, LLC.1Y2026-01-014008 Heritage Drive Brookshire TX US 77423
30329065743032906574Coloplast Manufacturing US LLC1N2026-01-01680 E Travelers Trl Ste 800 Burnsville MN US 55337
21253372125337COLOPLAST MANUFACTURING US LLC1N2020-04-251940 Commerce Dr North Mankato MN US 56003
30100524683010052468Coloplast Manufacturing US, LLC1N2020-04-254495 E Wall St Ontario CA US 91761
30121650361046831Coloplast Manufacturing US, LLC1Y2020-04-25475 Riverside Parkway Suite 400 Lithia Spgs GA US 30122

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
90771369373420P020003COLOPLAST SALINE-FILLED TESTICULAR PROSTHESISFAF2002-07-19
90771012210062P000006TITAN INFLATABLE PENILE PROSTHESISFHW2000-07-14
90801525424507K991202MODIFICATION TO WOUN'DRESMGQ1999-06-04
1879401525424507K991202MODIFICATION TO WOUN'DRESMGQ1999-06-04
1527231789041692K973070CONVEEN EASICATH SETEZD1997-11-06
1879401789041692K973070CONVEEN EASICATH SETEZD1997-11-06
90771356609227K944415ORIGIN TACKER SYSTEMOCW1994-11-28
90771931827456K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)PAH2024-10-18
90771332292165K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitOTM2023-09-25
3231821881526356K223821Self-Cath Closed SystemFCM2023-08-02
90771952048927K221874Altis Single Incision Sling SystemPAH2023-02-15
90771906284026K220420Saffron Fixation SystemPBQ2022-06-10
90771401773523K213186NovoFlow Reinforced Ureteral StentFAD2022-02-16
90771339843288K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kitsFAD2022-06-08
3231821180206725K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsLJE2022-03-10
90771874553927K201436Vortek Single Loop Ureteral StentFAD2021-02-25
1527231232889649K191536Biatain Silicone AgFRO2020-02-21
1879401232889649K191536Biatain Silicone AgFRO2020-02-21
1879401250002741K190620SpeediCath Flex Coude ProGBM2019-07-10
90772025273319K182831SabreLine and SabreGuard Laser FibersGEX2018-12-10
1879402025273319K182831SabreLine and SabreGuard Laser FibersGEX2018-12-10
90771982444827K182122Ureteric CathetersEYB2018-10-04
1879401982444827K182122Ureteric CathetersEYB2018-10-04
90771276052437K181811ReTrace Ureteral Access SheathFED2018-09-07
1879401276052437K181811ReTrace Ureteral Access SheathFED2018-09-07
90771662130889K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral StentFAD2018-11-06
1879401662130889K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral StentFAD2018-11-06
1527231857604852K180258SpeediCath StandardGBM2018-10-25
1879401857604852K180258SpeediCath StandardGBM2018-10-25
90771146467756K180057VORTEK URETERAL DOUBLE LOOP STENTFAD2018-03-09
1879401146467756K180057VORTEK URETERAL DOUBLE LOOP STENTFAD2018-03-09
90771773453675K173527Digitex Delivery DevicePWI2018-02-12
90772049026728K173501Meridian Vaginal Positioning System (VPS)PWK2018-02-09
3325422049026728K173501Meridian Vaginal Positioning System (VPS)PWK2018-02-09
90771134205747K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB2017-12-21
1879401134205747K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB2017-12-21
90772039312171K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSFAD2017-11-02
90771487418130K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSFAD2017-11-15
90771217803664K160766Ambu USR, Ambu MFAJ2016-08-17
1879401217803664K160766Ambu USR, Ambu MFAJ2016-08-17
90771399957817K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiffOCY2015-05-27
1879401399957817K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiffOCY2015-05-27
90771188674193K140116RESTORELLE Y CONTOUR MESHOTO2014-02-12
90771417177546K132061RESTORELLE M, RESTORELLE XLOTO2013-08-02
90771504864868K123914RESTORELLE Y CONTOUROTO2013-03-05
90771882664840K122968NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015OTO2012-12-18
90771741036400K122440RESTORELLE LOTO2012-11-19
1527231100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
1879401100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
3231821100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
90771230167469K121562ALTIS SINGLE INCISION CLING SYSTEMPAH2012-11-05
1527231498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
1879401498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
1527231780931743K121457SPEEDICATH COMPACT SET (12 FR)GBM2012-10-02
1879401780931743K121457SPEEDICATH COMPACT SET (12 FR)GBM2012-10-02
1879402009461569K120828BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHESFRO2012-04-05
90771346648272K120284DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEXNEW2012-05-23
90771512188655K113496VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KITOTM2012-02-14
1879401273308554K112860PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETERKNT2012-06-08
90771831478680K112386EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMOTP2011-09-08
90772061261249K112322RESTORELLE POLYPROPYLENE Y MESHOTO2012-05-17
90772070942186K111881VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KITOTM2011-08-17
90771821785839K111233SUPRIS RETROPUBIC SLING SYSTEMOTN2011-06-24
90771904089808K103568RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESHFTL2010-12-22
90771412980253K101297VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020OTM2010-06-03
1527231917523549K100878SELF CATH CATHETEREZD2010-05-26
1879401917523549K100878SELF CATH CATHETEREZD2010-05-26
1879401399213710K100218BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMFRO2010-02-17
90771316719289K093112DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGEGAW2010-02-01
90771095115586K091900ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICEGDW2009-07-16
90771020708125K090217BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070FBK2009-04-23
1527232041781369K082831AMSELF CLOSED CATHETERIZATION SYSTEMFCM2008-10-23
1879402041781369K082831AMSELF CLOSED CATHETERIZATION SYSTEMFCM2008-10-23
1527231098151627K072808SPEEDICATH COMPACTGBM2007-11-09
1879401098151627K072808SPEEDICATH COMPACTGBM2007-11-09
1527231804783612K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMFCM2007-06-01
1879401804783612K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMFCM2007-06-01
1527231089171433K061615INTERDRY TEXTILE WITH SILVERFRL2006-12-22
1879401089171433K061615INTERDRY TEXTILE WITH SILVERFRL2006-12-22
1527232021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
1879402021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
90772007081193K050148MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KITOTN2005-03-09
1879401606593199K041316ANTIMICROBIAL ALGINATE DRESSINGFRO2004-08-05
90771119003808K040959MENTOR GENESIS PENILE PROSTHESISFAE2004-10-29
1527231923071866K023254SPEEDICATHGBM2003-01-27
1879401923071866K023254SPEEDICATHGBM2003-01-27
1879401014143884K013921PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2XFAD2002-10-17
1527231173916940K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,EZL2002-01-04
1879401173916940K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,EZL2002-01-04
1527231119459327K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODELEZL2001-12-20
1879401119459327K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODELEZL2001-12-20
1527231318557118K003784MENTOR SELF-CATH PLUSEZL2001-03-05
1879401318557118K003784MENTOR SELF-CATH PLUSEZL2001-03-05
1527231119879315
1879401119879315
90771198410761
1527231215449625
1879401215449625
1527231221578967
1879401221578967
90771266369103
1527231274346639
1879401274346639
1527231283319432
1879401283319432
1527231343180288
1879401343180288
1527231381517784
1879401381517784
1527231398980614
1879401398980614
1527231414601841
1879401414601841
1527231471863104
1879401471863104
1879401474068973
90801476228152
1879401476228152
1527231554983951

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FAD112022-06-08
GBM112019-07-10
OTO62014-02-12
EZL62002-01-04
FCM52023-08-02
FRO52020-02-21
OTM42023-09-25
EYB42018-10-04
EZD42010-05-26
PAH32024-10-18
EXD32012-07-16
GEX22018-12-10
FED22018-09-07
PWK22018-02-09
FAJ22016-08-17
OCY22015-05-27
OTN22011-06-24
FRL22006-12-22
EZP22006-10-13
MGQ21999-06-04
PBQ12022-06-10
LJE12022-03-10
PWI12018-02-12
KNT12012-06-08
NEW12012-05-23
OTP12011-09-08
FTL12010-12-22
GAW12010-02-01
GDW12009-07-16
FBK12009-04-23
FAE12004-10-29
FAF12002-07-19
FHW12000-07-14
OCW11994-11-28

PMN#