FDA.reportPublic FDA data

Tara Turney

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80215451000477110Tara Turney1N2026-01-0120 Maguire Lexington MA US 02420
96180033003264198Tara Turney1N2026-01-0120 Maguire Lexington, MA MA US 03841
30088068093008806809Tara Turney1N2026-01-0120 Maguire Lexington, MA MA US 03841

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
99041316544487K991759MAERSK MEDICAL CONTOUR INFUSION SETFPA1999-06-25
1144441223202219K973076EUROMEDICAL HAEMATURIA FOLEY CATHETEREZL1998-09-16
99041493322155K972135MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SETFPA1997-08-26
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
99041634770474K945617PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETSFPA1995-02-13
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
99041125014385K881767VIGGO INSUFLONFOZ1988-08-24
1144441109876878K874517PHARMASEAL RUBBER URETHRAL CATHETERKOD1987-12-03
1144441374029343K873286DISPOSABLE, MANUAL PULMONARY RESUSCITATORBTM1987-10-26
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
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
1144441763827780K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM2022-06-22
99041932819209K210544Medtronic Extended infusion setFPA2021-07-16
99041252821406K192647neria guard Infusion SetFPA2019-12-13
361861623990277K190114Flexi-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
1144441273045649K181206GentleCath Glide Intermittent Urinary CatheterGBM2018-08-16
1144441687694772K180205AVELLE Negative Pressure Wound Therapy SystemOMP2018-10-19
99041530715543K173879MiniMed Mio Advance infusion setFPA2018-03-05
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
1144442005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
99041939259795K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion SetFPA2017-11-01
1144441777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
99041095844366K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®FPA2016-08-10
361861747996319K152926AQUACEL Ag Surgical SP DressingFRO2016-01-21
1144441747996319K152926AQUACEL Ag Surgical SP DressingFRO2016-01-21
361861945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1144441945556625K150350Flexi-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
99041598715279K132142NERIA SOFT 90 INFUSION SETFPA2013-10-08
1144441516537495K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFRO2013-06-06
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
99041667456802K120872ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSFPA2012-04-20
99041840849829K120395NERIA MULTI SUBCUTANEOUS INFUSION SETFPA2012-05-30
99042069276138K120337I-PORT ADVANCE INJECTION PORTFOZ2012-02-16
1144441995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
1144441424854778K110653CURE CATHETEREZD2011-08-01
361861754780492K091034AQUACEL AG SURGICALFRO2009-12-16
1144441754780492K091034AQUACEL AG SURGICALFRO2009-12-16
1144441844093946K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)FRO2009-09-04
1144442015114804K080881CURE CATHETER CLOSED SYSTEMKOD2008-06-11
1144441693345941K080383AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSINGFRO2008-05-02
1144441336986445K072539CURE CATHETEREZD2007-09-13
99041407896781K070430PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETSFPA2007-04-04
1144441518845498K063271AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSINGFRO2007-04-16
99041576697062K061374INTUITION INFUSION SETSFPA2006-07-31
99041924094123K051264COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPSFPA2005-09-01
99041156702554K041545CONTACT DETACHFPA2004-06-30
99041099193729K040633CLICK-ONFPA2004-04-01
99041104553153K032854UNOMEDICAL MONICA INFUSION SETFPA2003-10-09
1144441508716359K032734CONVATEC FECAL MANAGEMENT SYSTEMKNT2004-04-08
1144442054505273K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGFRO2002-06-21
99041393100409K011071PARADIGM QUICK-SET INFUSION SETFPA2001-06-07
99041825802851K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380FPA2000-08-29
1144441040252185
1144441050013298
1144441078855763
1144441084359034
361861104077379
1144441104077379
1144441128793855
1144441136695721
1144441157005164
1144441163806697
361861164774439
361861192756328
1144441192756328
1144441225019847
1144441231780541
1144441258268498
361861350933909
1144441350933909
1144441362325805
361861372449025
1144441372449025
1144441374727462
361861426895164
1144441426895164
1144441436005302
1144441437409350
361861466573805
1144441466573805
1144441507721122
1144441542020585
1144441580661017

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA222021-07-16
FRO112018-07-20
KNT102025-03-28
EZD72026-04-01
KOD72017-11-21
EZL41998-09-16
EXD41983-08-26
EXB41981-06-16
BTR31996-11-21
GBM22022-06-22
FOZ22012-02-16
EFQ21981-02-13
FCM12025-06-06
OMP12018-10-19
JOH11994-12-27
CAH11994-11-30
CCK11992-02-11
FPD11990-12-21
BTM11987-10-26
NAD11986-08-20
KNX11984-08-08
CAF11979-09-07
BTT11976-08-13