ACCESS

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1811250	1000517901	ACCESS BUSINESS GROUP LLC	1	Y	2026-01-01	7575 EAST FULTON ST. ADA MI US 49355
3004902874	3004902874	ACCESS OPTICS	1	N	2026-01-01	2201 NORTH MAPLE AVE. Broken Arrow OK US 74012
3005402529	3005402529	ACCESS POINT TECHNOLOGIES, EP INC.	1	N	2026-01-01	12560 FLETCHER LANE SUITE 300 Rogers MN US 55374
3012505893	3012505893	ACCESSIBILITY SERVICES, INC.	1	N	2026-01-01	6241 S Tex Pt Homosassa FL US 34448
3016587599	3016587599	Access Pro Medical	1	Y	2026-01-01	804 Scott Nixon Memorial Dr. Augusta GA US 30907
3021570645	3021570645	ACCESS VASCULAR, INC	1	N	2026-01-01	749 Middlesex Turnpike Billerica MA US 01821
3024756665	3024756665	Access Bio, Inc.	1	N	2026-01-01	7 Fitzgerald Ave Monroe Township NJ US 08831
3003966368	3008474767	ACCESS BIO INCORPORATE	1	Y	2020-04-25	65 Clyde Rd Ste A Somerset NJ US 08873
3005402529	3005402529	ACCESS POINT TECHNOLOGIES, EP INC.	1	N	2020-04-25	12560 FLETCHER LANE SUITE 300 Rogers MN US 55374
3009549229	3009549229	ACCESS SCIENTIFIC, LLC	1	N	2020-04-25	3910 Sorrento Valley Blvd Ste 200 San Diego CA US 92121
3013520846	3013520846	ACCESSORY INNOVATIONS, LLC	1	Y	2020-04-25	34 West 33rd Street Suite 600 New York NY US 10001
3014658399	3014658399	ACCESS DENTAL LAB, LLC	1	Y	2020-04-25	1530 Antioch Pike Antioch TN US 37013
3015060232	3015060232	ACCESS VASCULAR, INC	1	N	2020-04-25	175 Middlesex Turnpike Bedford MA US 01730

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
220134	1244123703	K981095	ALIGN SYSTEM	NXC	1998-09-08
150929	1137741655	K973958	GENERAL PURPOSE ATL NEEDLE GUIDE KIT	ITX	1998-01-22
310252	1399528652	K251604	CareSuperb COVID-19/Flu A&B Antigen Combo Home Test	SCA	2025-08-22
337420	1393986977	K250590	MAGiC Sweep™ EP Mapping Catheter	DRF	2025-07-23
302433	1245117215	K244059	HydroMID 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)	FOZ	2025-03-27
302433	1732983007	K243458	HydroPICC 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); Hydr	LJS	2025-08-01
310252	2055607328	K241915	CareSuperb™ COVID-19 Antigen Home Test	QYT	2025-01-29
302433	1503527291	K220772	HydroMID 4F Single Lumen Midline Catheter	FOZ	2022-12-07
302433	1502499980	K213550	HydroPICC 5F Dual Lumen Catheter	LJS	2022-05-04
302433	1741849928	K203069	HydroMID	FOZ	2021-02-08
223048	1524319324	K193015	HydroPICC (PICC-142)	LJS	2020-02-20
302433	1524319324	K193015	HydroPICC (PICC-142)	LJS	2020-02-20
220134	1539128961	K191990	OSW Aligner System	NXC	2019-08-23
150929	1616089227	K183066	The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model	DYB	2019-07-25
150929	1028265025	K182243	The CVC WAND Safety Introducer with Valved Peelable Sheath	DYB	2018-09-18
150929	1942654106	K181563	The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology	DQY	2018-09-26
150929	1563592855	K162322	the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model	DYB	2016-11-17
337420	1115905998	K160390	Map-it Diagnostic Mapping Catheters	DRF	2016-04-11
199837	1966948675	K160390	Map-it Diagnostic Mapping Catheters	DRF	2016-04-11
150929	1389109690	K131300	THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER	DYB	2013-06-07
150929	1118520700	K131148	THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH	DYB	2013-09-04
220134	1061155579
150929	1222995262
220134	1259120194
220134	1306643711
98026	1351714554
98026	1416333587
150929	1453792517
98026	1537185909
150929	1563305302
220134	1593577534
220134	1611754928
220134	1671245651
220134	1804418230
98026	1826780847
98026	1851304182
98026	1890369568
98026	1906770399
220134	1938799983
199837	1998201112
310252	1061750371
337420	1179680976
194466	1220123963
310252	1273170653
310252	1351714554
310252	1414620313
310252	1416344332
337420	1639298584
310252	1754264603
310252	1851304182
67385	1870301607
310252	1952226709

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DYB	5	2019-07-25
LJS	4	2025-08-01
DRF	3	2025-07-23
FOZ	3	2025-03-27
NXC	2	2019-08-23
SCA	1	2025-08-22
QYT	1	2025-01-29
DQY	1	2018-09-26
ITX	1	1998-01-22

NDC#

Satinique Anti Dandruff
Access Business Group LLC
PYRITHIONE ZINC
g and h Protect Body
Access Business Group LLC
ENSULIZOLE, OCTISALATE, ZINC OXIDE
g and h Protect Hand
Access Business Group LLC
BENZALKONIUM CHLORIDE
Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - Light
Access Business Group LLC
ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
Artistry Skin Nutrition BALANCING Matte Day
Access Business Group LLC
AVOBENZONE, OCTISALATE, OCTOCRYLENE
Artistry Skin Nutrition HYDRATING Day
Access Business Group LLC
AVOBENZONE, OCTISALATE, OCTOCRYLENE
Artistry Studio Done With Zit Acne Treatment Clearing Gel
Access Business Group LLC
SALICYLIC ACID
Artistry Skin Nutrition RENEWING Reactivation Day Cream SPF 30
Access Business Group LLC
AVOBENZONE, OCTISALATE, OCTOCRYLENE
Artistry Skin Nutrition RENEWING Reactivation Day SPF 30
Access Business Group LLC
AVOBENZONE, OCTISALATE, OCTOCRYLENE
ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore Refresher
Access Business Group LLC
SALICYLIC ACID
Glister Multi-Action
Access Business Group LLC
SODIUM FLUORIDE
Artistry Skin Nutrition Multi-Defense UV Protect
Access Business Group LLC
ZINC OXIDE, TITANIUM DIOXIDE
G and H Protect Hand Sanitizer
Access Business Group LLC
ALCOHOL
GandH Protect Antiperspirant Deodorant Roll On
Access Business Group LLC
ALUMINUM CHLOROHYDRATE
Satinique Anti Dandruff Scalp and Hair
Access Business Group LLC
SALICYLIC ACID

PMA#

MynxGrip, Mynx Ace, and Mynx Control Vascular Closure (VCD)
2019-10-03
ACCESS CLOSURE, INC.
Mynx CONTROL Vascular Closure
2019-06-21
ACCESS CLOSURE, INC.
MynxGrip, Mynx Ace and Mynx Control Vascular Closure (VCD)
2019-03-14
ACCESS CLOSURE, INC.
MynxGrip and Mynx Ace Vascular Closure
2018-11-16
ACCESS CLOSURE, INC.
Mynx Control Vascular Closure
2018-09-10
ACCESS CLOSURE, INC.
MynxGrip Vascular Closure , Mynx Ace Vascular Closure
2018-09-06
ACCESS CLOSURE, INC.
MynxGrip Vascular Closure
2018-07-10
ACCESS CLOSURE, INC.
MynxGrip, Mynx Ace Vascular Closure (VCD)
2018-04-27
ACCESS CLOSURE, INC.
MynxGrip Vascular Closure
2017-09-28
ACCESS CLOSURE, INC.
MYNXGRIP VASCULAR CLOSURE DEVICE
2017-06-28
ACCESS CLOSURE, INC.
MynxGrip Vascular Closure
2017-05-26
ACCESS CLOSURE, INC.
MYNXGRIP AND MYNX ACE VASCULAR CLOSURE DEVICE
2016-09-23
ACCESS CLOSURE, INC.
MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F)
2016-09-06
ACCESS CLOSURE, INC.
MYNX ACE VASCULAR CLOSURE DEVICE
2016-07-06
ACCESS CLOSURE, INC.
MATRIX VASCULAR CLOSURE SYSTEM (VSG)
2016-05-04
ACCESS CLOSURE, INC.
MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE )
2016-03-10
ACCESS CLOSURE, INC.
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
2016-01-31
ACCESS CLOSURE, INC.
MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP)
2015-12-03
ACCESS CLOSURE, INC.
MYNXGRIP VASCULAR CLOSURE DEVICES
2015-08-03
ACCESS CLOSURE, INC.
MYNX ACE VASCULAR CLOSURE DEVICE
2015-08-03
ACCESS CLOSURE, INC.
5F MYNXGRIP VASCULAR CLOSURE DEVICE (MX5021)
2015-07-28
ACCESS CLOSURE, INC.
MYNXGRIP VASCULAR CLOSURE DEVICE
2015-04-24
ACCESS CLOSURE, INC.
MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE)
2015-03-03
ACCESS CLOSURE, INC.
THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
2015-01-09
ACCESS CLOSURE, INC.
MYNX ACE VASCULAR CLOSURE DEVICE
2015-01-09
ACCESS CLOSURE, INC.
MYNXGRIP VASCULAR CLOSURE DEVICE
2014-11-25
ACCESS CLOSURE, INC.
MYNX ACE VASCULAR CLOSURE DEVICE
2014-08-18
ACCESS CLOSURE, INC.
MYNXGRIP VASCULAR CLOSURE DEVICE
2014-07-30
ACCESS CLOSURE, INC.
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY)
2014-06-18
ACCESS CLOSURE, INC.
THE MYNX VASCULAR CLOSURE DEVICE PRODCUT FAMILY
2014-05-08
ACCESS CLOSURE, INC.
MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES
2014-05-01
ACCESS CLOSURE, INC.
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
2014-04-30
ACCESS CLOSURE, INC.
MYNX VASCULAR CLOSURE DEVICE
2014-04-24
ACCESS CLOSURE, INC.
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (MYNX PRODUCT FAMILY)
2014-03-28
ACCESS CLOSURE, INC.
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
2014-01-24
ACCESS CLOSURE, INC.
MYNX ACE VASCULAR CLOSURE DEVICE (6F/7F)
2013-08-19
ACCESS CLOSURE, INC.
MYNX VASCULAR CLOSURE DEVICE
2013-07-22
ACCESS CLOSURE, INC.
MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES
2013-05-17
ACCESS CLOSURE, INC.
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
2013-01-24
ACCESS CLOSURE, INC.
MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES
2013-01-09
ACCESS CLOSURE, INC.

82 records. Showing 1-40. Next

PMN#

ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS
1995-01-12
ACCESS SURGICAL INTL., INC.
ACCESS POINT
1994-11-08
ACCESS SURGICAL INTL., INC.
FLEX-I-PORT
1994-03-29
ACCESS SURGICAL INTL., INC.
ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.
1993-11-18
ACCESS SURGICAL INTL., INC.
BATTERY PACKS (VARIOUS MODELS)
1993-07-13
ACCESS / GOD LOVES YOU
BATTERY PACKS
1992-12-17
ACCESS / GOD LOVES YOU
ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM.
1992-11-25
ACCESS SURGICAL INTL., INC.
ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM.
1992-11-18
ACCESS SURGICAL INTL., INC.
ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM
1992-11-17
ACCESS SURGICAL INTL., INC.
MEDICAL BATTERY PACKS
1992-09-30
ACCESS / GOD LOVES YOU
MEDICAL BATTERY PACKS
1992-09-23
ACCESS / GOD LOVES YOU
CENTRAL VEIN CATHERIZATION KIT
1983-02-23
ACCESS DEVICES, INC.
INTRAVENOUS CATHETER PLACEMENT UNIT &
1982-11-01
ACCESS DEVICES, INC.
ACCESS PERCUTANEOUS INTRODUCER SET
1982-11-01
ACCESS DEVICES, INC.

54 records. Showing 41-54. Previous

GUDID#

CareSuperb COVID-19/Flu A&B Antigen Combo External Control - SCNM-00171
Access Bio Inc.
2026-06-08
CareSuperb COVID-19/FluA&B Antigen Combo Test - RCNM-02071
Access Bio Inc.
2026-06-08
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-5-2mm, 0-5-5-5-5mm, 130cm
ACCESS POINT TECHNOLOGIES, INC.
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 13-2-10-13-2mm, 130cm
ACCESS POINT TECHNOLOGIES, INC.
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 0-16-2-2-16mm, 130cm
ACCESS POINT TECHNOLOGIES, INC.
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 0-13-0-5-5mm, 130cm
ACCESS POINT TECHNOLOGIES, INC.
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 0-5-5-5-5mm, 130cm
ACCESS POINT TECHNOLOGIES, INC.
2026-05-15
MAGiC Sweep - MAGiC Sweep, 5/8F, 2-2-2mm, 13-5-0-5-5mm, 130cm
ACCESS POINT TECHNOLOGIES, INC.
2026-05-15
Mynx Ace Vascular Closure Device (6F/7F) - MX6740
Access Closure, Inc.
2017-02-06
CareSuperb COVID-19 Antigen Home Test - RCTM-00571
Access Bio Inc.
2026-01-05
CareSuperb COVID-19 Antigen Home Test - RCTM-00271
Access Bio Inc.
2026-01-05
CareSuperb COVID-19 Antigen Home Test - RCTM-00171
Access Bio Inc.
2026-01-05
CareSuperb COVID-19/FluA&B Antigen Combo Home Test - RCUM-00571
Access Bio Inc.
2025-12-24
CareSuperb COVID-19/FluA&B Antigen Combo HomeTest - RCUM-02071
Access Bio Inc.
2025-09-30
CareSuperb COVID-19/FluA&B Antigen Combo HomeTest - RCUM-00271
Access Bio Inc.
2025-09-30
CareSuperb COVID-19/FluA&B Antigen Combo HomeTest - RCUM-00171
Access Bio Inc.
2025-09-30
MynxGrip Vascular Closure Device (6F/7F) - MX6721
Access Closure, Inc.
2017-02-06
MynxGrip Vascular Closure Device (5F) - MX5021
Access Closure, Inc.
2017-02-06
Paxwire Occlusion Balloon System - The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery.
Access Closure, Inc.
2016-05-09
SmileDirectClub Retainer - SmileDirectClub Retainers consist of a clear plastic removable orthodontic appliance which are intended to hold the teeth in their current position.
Access Dental Lab, LLC
2023-11-30
ALIGNER SEATER PURPLE - ALIGNER SEATER WITH PURPLE COLORING
Access Dental Lab, LLC
2023-02-17
IMPRESSION TRAY XLG - IMPRESSION TRAY EXTRA LARGE
Access Dental Lab, LLC
2023-02-17
IMPRESSION TRAY LRG - IMPRESSION TRAY LARGE SIZE
Access Dental Lab, LLC
2023-02-17
IMPRESSION TRAY MED - IMPRESSION TRAY MEDIUM SIZE
Access Dental Lab, LLC
2023-02-17
IMPRESSION TRAY SM - IMPRESSION TRAY SMALL SIZE
Access Dental Lab, LLC
2023-02-17
Impression Tray XSM - Impression Tray Extra Small
Access Dental Lab, LLC
2023-02-17
Smile stretcher-purple bag - Smile stretcher in foil purple pouch
Access Dental Lab, LLC
2023-02-17
SDC-impression material (Kulzer) - putty material used to create dental impressions.
Access Dental Lab, LLC
2023-02-17
SDC impression material (Zest) - impression material used to create dental impressions
Access Dental Lab, LLC
2023-02-17
NIGHTTIME -REP - REPLACEMENT ALIGNERS
Access Dental Lab, LLC
2022-12-09
NIGHTTIME ALIGNERS - REF - REFINEMENT ALIGNERS
Access Dental Lab, LLC
2022-12-09
NIGHTTIME ALIGNERS-MCC - MID-COURSE CORRECTION
Access Dental Lab, LLC
2022-12-09
NIGHTTIME CLEAR ALIGNERS - SEQUENTIAL ALIGNERS- INITIAL
Access Dental Lab, LLC
2022-12-09
SDC Aligners-REP - REPLACEMENT ALIGNERS
Access Dental Lab, LLC
2022-12-09
SDC Aligners-REF - REFINEMENT CORRECTION
Access Dental Lab, LLC
2022-12-09
SDC ALIGNERS MCC - Mid-Course Correction aligners
Access Dental Lab, LLC
2022-12-09
SDC Aligners- - Sequential -initial
Access Dental Lab, LLC
2022-12-07
REPLACEMENT ALIGNERS - 100-0355
Access Dental Lab, LLC
2019-06-06
RETAINER KIT - 100-0354
Access Dental Lab, LLC
2019-06-06
REFINEMENT CORRECTION KIT - 100-0012
Access Dental Lab, LLC
2019-06-06

80 records. Showing 1-40. Next