ACCESS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18112501000517901ACCESS BUSINESS GROUP LLC1Y2026-01-017575 EAST FULTON ST. ADA MI US 49355
30049028743004902874ACCESS OPTICS1N2026-01-012201 NORTH MAPLE AVE. Broken Arrow OK US 74012
30054025293005402529ACCESS POINT TECHNOLOGIES, EP INC.1N2026-01-0112560 FLETCHER LANE SUITE 300 Rogers MN US 55374
30125058933012505893ACCESSIBILITY SERVICES, INC.1N2026-01-016241 S Tex Pt Homosassa FL US 34448
30165875993016587599Access Pro Medical1Y2026-01-01804 Scott Nixon Memorial Dr. Augusta GA US 30907
30215706453021570645ACCESS VASCULAR, INC1N2026-01-01749 Middlesex Turnpike Billerica MA US 01821
30247566653024756665Access Bio, Inc.1N2026-01-017 Fitzgerald Ave Monroe Township NJ US 08831
30039663683008474767ACCESS BIO INCORPORATE1Y2020-04-2565 Clyde Rd Ste A Somerset NJ US 08873
30054025293005402529ACCESS POINT TECHNOLOGIES, EP INC.1N2020-04-2512560 FLETCHER LANE SUITE 300 Rogers MN US 55374
30095492293009549229ACCESS SCIENTIFIC, LLC1N2020-04-253910 Sorrento Valley Blvd Ste 200 San Diego CA US 92121
30135208463013520846ACCESSORY INNOVATIONS, LLC1Y2020-04-2534 West 33rd Street Suite 600 New York NY US 10001
30146583993014658399ACCESS DENTAL LAB, LLC1Y2020-04-251530 Antioch Pike Antioch TN US 37013
30150602323015060232ACCESS VASCULAR, INC1N2020-04-25175 Middlesex Turnpike Bedford MA US 01730

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2201341244123703K981095ALIGN SYSTEMNXC1998-09-08
1509291137741655K973958GENERAL PURPOSE ATL NEEDLE GUIDE KITITX1998-01-22
3102521399528652K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestSCA2025-08-22
3374201393986977K250590MAGiC Sweep™ EP Mapping CatheterDRF2025-07-23
3024331245117215K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)FOZ2025-03-27
3024331732983007K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrLJS2025-08-01
3102522055607328K241915CareSuperb™ COVID-19 Antigen Home TestQYT2025-01-29
3024331503527291K220772HydroMID 4F Single Lumen Midline CatheterFOZ2022-12-07
3024331502499980K213550HydroPICC 5F Dual Lumen CatheterLJS2022-05-04
3024331741849928K203069HydroMIDFOZ2021-02-08
2230481524319324K193015HydroPICC (PICC-142)LJS2020-02-20
3024331524319324K193015HydroPICC (PICC-142)LJS2020-02-20
2201341539128961K191990OSW Aligner SystemNXC2019-08-23
1509291616089227K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr ModelDYB2019-07-25
1509291028265025K182243The CVC WAND Safety Introducer with Valved Peelable SheathDYB2018-09-18
1509291942654106K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD TechnologyDQY2018-09-26
1509291563592855K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelDYB2016-11-17
3374201115905998K160390Map-it Diagnostic Mapping CathetersDRF2016-04-11
1998371966948675K160390Map-it Diagnostic Mapping CathetersDRF2016-04-11
1509291389109690K131300THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERDYB2013-06-07
1509291118520700K131148THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATHDYB2013-09-04
2201341061155579
1509291222995262
2201341259120194
2201341306643711
980261351714554
980261416333587
1509291453792517
980261537185909
1509291563305302
2201341593577534
2201341611754928
2201341671245651
2201341804418230
980261826780847
980261851304182
980261890369568
980261906770399
2201341938799983
1998371998201112
3102521061750371
3374201179680976
1944661220123963
3102521273170653
3102521351714554
3102521414620313
3102521416344332
3374201639298584
3102521754264603
3102521851304182
673851870301607
3102521952226709

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB52019-07-25
LJS42025-08-01
DRF32025-07-23
FOZ32025-03-27
NXC22019-08-23
SCA12025-08-22
QYT12025-01-29
DQY12018-09-26
ITX11998-01-22

NDC#

PMA#

82 records. Showing 1-40. Next

PMN#

54 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next