FDA.reportPublic FDA data

Jessica Oswald-McLeod

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80203473005612924Jessica Oswald-McLeod1N2027-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027
30078357163007835716Jessica Oswald-McLeod1N2027-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027
30300421693030042169Jessica Oswald-McLeod1N2027-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027
30447783323044778332Jessica Oswald-McLeod1N2027-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027
80411453002974635Jessica Oswald-McLeod1N2026-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027
96109873002807710Jessica Oswald-McLeod1N2026-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027
30041385173004138517Jessica Oswald-McLeod1N2026-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027
30111429813011142981Jessica Oswald-McLeod1N2026-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027
30162502523016250252Jessica Oswald-McLeod1N2026-01-013100 SW 145th Ave., Suite 100 Miramar FL US 33027

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
95501432859851K963748BIO-PLEXUS DROP-IT NEEDLE HOLDERFMI1997-06-06
105661713111404K960051NIPRO SAFELET CATHFOZ1996-03-28
105651301453505K955182NIPRO ARTERIAL VENOUS FISTULA NEEDLEFIE1996-06-04
105651940095743K955053NIPRO SCALP VEIN SET (DISPOSABL PSV SET)FOZ1996-01-04
105651507242319K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLESFMF1994-12-07
95501343522491K850009EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETERBSO1985-05-13
95501012974522K833112TUBING FOR CARDIOPULMONARY BYPASSDWF1983-11-28
105661915036957K261399ELISIO™-HXQAX2026-07-28
105661988661620K260533ELISIO™-HKDI2026-03-19
2336321675915674K243944Aperta NSE PTA Balloon Dilatation CatheterPNO2025-04-22
3404961675915674K243944Aperta NSE PTA Balloon Dilatation CatheterPNO2025-04-22
2336321745163351K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)PNO2024-03-28
3404961745163351K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)PNO2024-03-28
105651524524371K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleFMI2023-05-25
1905081773245441K190037Cronus HP PTA Balloon CatheterLIT2019-10-24
105661156555585K182940Surdial DX Hemodialysis SystemKDI2019-07-19
105651156555585K182940Surdial DX Hemodialysis SystemKDI2019-07-19
2359531156555585K182940Surdial DX Hemodialysis SystemKDI2019-07-19
105651565555997K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)FMI2018-01-17
105651555764879K161681Nipro SafeTouch IV CatheterFOZ2017-03-08
105662023620190K160444FB-U HemodialyzerKDI2017-02-08
105661411322168K140191ELISIO-H HEMODIALYZERKDI2014-04-14
105651658845196K140136NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICEFOZ2014-02-14
105661739293837K131935ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZERKDI2013-12-20
105651931480857K131641MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)FMF2013-08-28
105652069662393K130049MONOJECT 12ML SYRINGEFMF2013-02-14
105651720892706K113471NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SETFPA2012-10-18
105651678168029K113470NIPRO SAFE TOUCH HUBER INFUSION SETFPA2012-10-17
105651011747967K113469NIPRO HUBER INFUSION, EXCEL HUBER NEEDLEFMI2012-10-18
105651190582556K112628NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SETFJK2012-09-28
105651524335503K100520NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVERFIE2010-03-17
95501810651847K080174PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1CLHI2008-04-23
105651295124603K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1FIB2008-02-21
105651267841372K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693FJK2007-10-04
105651386006507K071145NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLEMPB2007-09-07
105651648441089K063721NIPRO SAFETOUCH II GAMMAFIE2007-01-12
105701918428176K052474NIPRO HYPODERMIC NEEDLEFMI2005-11-10
95501755157727K04267214F DUAL FLOATING DIALYSIS CATHETER/TRAYMSD2005-03-23
105651268368564K032777MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLEFOZ2003-11-14
105651598002767K011297NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SETFOZ2001-06-20
95501456211774
95502067657039
3499121086552474
2336321121871919
105661165739184
105651297668016
95501307560346
105661319420249
105661331721592
95501424920566
105651454390385
105651459467599
105651521821980
105651533504244
105661662386625
105661666648627
105661698693765
105651714532173
105651803477117
2336321833740132
105651901048813
95502013830685

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FOZ102017-03-08
KDI82026-03-19
FMI72023-05-25
FMF62013-08-28
FIE52010-03-17
PNO42025-04-22
FPA42012-10-18
FJK42012-09-28
LIT22019-10-24
FIB22008-02-21
MPB22007-09-07
QAX12026-07-28
LHI12008-04-23
MSD12005-03-23
BSO11985-05-13
DWF11983-11-28