FDA.report

Courtney Smith

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96180033003264198Courtney Smith1N2026-01-0120 Maguire Lexington, MA MA US 03841
10003175711000317571Courtney Smith1N2026-01-0120 Maguire Lexington, MA MA US 03841
30034423803003442380Courtney Smith1N2026-01-0120 Maguire Lexington MA US 02420
30088068093008806809Courtney Smith1N2026-01-0120 Maguire Lexington, MA MA US 03841
30128817403012881740Courtney Smith1N2026-01-0120 Maguire Lexington, MA MA US 03841

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1144441223202219K973076EUROMEDICAL HAEMATURIA FOLEY CATHETEREZL1998-09-16
1144441113729483K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBEBTR1996-11-21
1144442016582059K954752PEDIATRIC EUROPHYLIC FOLEY CATHETEREZL1995-10-30
1144442001848651K951697PEDIATRIC ENDOTRACHEAL TUBEBTR1995-05-22
1144441802119416K951696ENDOTRACHEAL TUBEBTR1995-05-22
1144441226586775K945874EUROMEDICAL POLY TRACHEOTOMY TUBEJOH1994-12-27
1144441668174056K945806SILICATH ALL SILICONE FOLEY CATHETEREZL1995-03-21
1144441459039740K944007EUROPHILIC SLIPPERY COATED FOLEY CATHETEREZL1995-06-29
1144441217228519K915750DISPOSABLE BACTERIAL BREATHNG FILTERCAH1994-11-30
1144441684368274K915228DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNULCCK1992-02-11
1144442054476910K896734FEEDING TUBEFPD1990-12-21
1144441554131193K896729NELATON-, FEMALE - OR TIEMANN CATHETERKOD1990-11-05
1144441109876878K874517PHARMASEAL RUBBER URETHRAL CATHETERKOD1987-12-03
1144441374029343K873286DISPOSABLE, MANUAL PULMONARY RESUSCITATORBTM1987-10-26
361871897993971K862935WOUND MANAGER(TM) - STERILENAD1986-08-20
1144441897993971K862935WOUND MANAGER(TM) - STERILENAD1986-08-20
1144441519889704K842395SUR-FIT NIGHT DRAINAGE CONTAINER SETKNX1984-08-08
1144441226737647K841544AMER. PHARMASEAL SILICONIZED LATEXKOD1984-07-09
361861395607584K832299VISI-FLOW IRRIGATOREXD1983-08-26
1144441395607584K832299VISI-FLOW IRRIGATOREXD1983-08-26
361861980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
361871980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
1144441980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
361861531848327K811239SUR-FIT DISPOSABLE CONVEX INSERTEXB1981-06-09
1144441531848327K811239SUR-FIT DISPOSABLE CONVEX INSERTEXB1981-06-09
361861565691994K811160SUR-FIT IRRIGATION SLEEVEEXD1981-06-02
1144441565691994K811160SUR-FIT IRRIGATION SLEEVEEXD1981-06-02
361861036121330K810200OPTIPORE SCRUB SPONGEEFQ1981-02-13
1144441036121330K810200OPTIPORE SCRUB SPONGEEFQ1981-02-13
1144441206633653K791536DISPOSABLE MEDICATION NEBULIZERCAF1979-09-07
1144441742284325K770256CATHETERS, SILICONE COATEDKOD1977-02-17
1144441531414218K760372HUMIDIFIER, DISPOSABLEBTT1976-08-13
1144441481946500K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD2026-04-01
1144441179686771K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CFCM2025-06-06
1144441191079854K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)EZD2025-07-01
361861635474744K243228Flexi-Seal AIR (with ENFit Connector)KNT2025-03-28
1144441635474744K243228Flexi-Seal AIR (with ENFit Connector)KNT2025-03-28
1144441081320490K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)EZD2024-01-25
361871808274185K230400Cure Catheter Closed System; Cure Dextra Closed SystemEZD2023-11-08
361871757976397K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD2022-11-17
1144441763827780K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM2022-06-22
361861623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
361871623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1144441623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1997261623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1144441273045649K181206GentleCath Glide Intermittent Urinary CatheterGBM2018-08-16
1144441687694772K180205AVELLE Negative Pressure Wound Therapy SystemOMP2018-10-19
361871000402544K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO2018-07-20
1144441000402544K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO2018-07-20
1144441816367477K172924GentleCath Intermittent Urinary CatheterKOD2017-11-21
361862005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
361872005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
1144442005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
1997262005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
361871777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
1144441777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
361861747996319K152926AQUACEL Ag Surgical SP DressingFRO2016-01-21
1144441747996319K152926AQUACEL Ag Surgical SP DressingFRO2016-01-21
361861945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
361871945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1144441945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1997261945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1144441449037304K132500CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATEDEZD2013-12-23
99081598715279K132142NERIA SOFT 90 INFUSION SETFPA2013-10-08
361871516537495K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFRO2013-06-06
1144441516537495K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFRO2013-06-06
361871114474239K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERFRO2012-07-25
1144441114474239K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERFRO2012-07-25
1144441664908441K120872ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSFPA2012-04-20
99081667456802K120872ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSFPA2012-04-20
361871995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
1144441995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
1997261995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
1144441424854778K110653CURE CATHETEREZD2011-08-01
361861754780492K091034AQUACEL AG SURGICALFRO2009-12-16
1144441754780492K091034AQUACEL AG SURGICALFRO2009-12-16
361871844093946K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)FRO2009-09-04
1144441844093946K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)FRO2009-09-04
1144442015114804K080881CURE CATHETER CLOSED SYSTEMKOD2008-06-11
361871693345941K080383AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSINGFRO2008-05-02
1144441693345941K080383AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSINGFRO2008-05-02
1144441336986445K072539CURE CATHETEREZD2007-09-13
99081407896781K070430PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETSFPA2007-04-04
361871518845498K063271AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSINGFRO2007-04-16
1144441518845498K063271AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSINGFRO2007-04-16
99081924094123K051264COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPSFPA2005-09-01
99081156702554K041545CONTACT DETACHFPA2004-06-30
1144441508716359K032734CONVATEC FECAL MANAGEMENT SYSTEMKNT2004-04-08
1997261508716359K032734CONVATEC FECAL MANAGEMENT SYSTEMKNT2004-04-08
361872054505273K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGFRO2002-06-21
1144442054505273K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGFRO2002-06-21
99081393100409K011071PARADIGM QUICK-SET INFUSION SETFPA2001-06-07
361871372449025
1144441040252185
1144441050013298
1144441078855763
1144441084359034
99081095844366
361861104077379
1144441104077379
99081104553153
99081125014385
1144441128793855
1144441136695721
99081156702554
1144441157005164
1144441163806697
361861164774439
361871164774439
361861192756328
361871192756328
1144441192756328
1144441225019847
1144441231780541
99081252821406
361871258268498
1144441258268498
99081316544487
361861350933909

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KNT192025-03-28
FRO182018-07-20
EZD92026-04-01
KOD82017-11-21
FPA72013-10-08
EXB51981-06-16
EZL41998-09-16
EXD41983-08-26
BTR31996-11-21
GBM22022-06-22
NAD21986-08-20
EFQ21981-02-13
FCM12025-06-06
OMP12018-10-19
JOH11994-12-27
CAH11994-11-30
CCK11992-02-11
FPD11990-12-21
BTM11987-10-26
KNX11984-08-08
CAF11979-09-07
BTT11976-08-13