FDA.reportPublic FDA data

ONE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20243752024375ONE LAMBDA, INC.1N2026-01-0122801 Roscoe Blvd. West Hills CA US 91304
30009790223000979022ONESPAWORLD (BAHAMAS) LIMITED F.K.A. STEINER TRANSOCEAN LIMITED1Y2026-01-01770 South Dixey Highway Second Floor Coconut Grove FL US 33146
30101525573010152557ONESTOPDENTALSTUDIO INC1N2026-01-01968 Durfee ave South El Monte CA US 91733
30113497353011349735ONESIXONE CORP1Y2026-01-01568 W 161ST ST New York NY US 10032
30130257773013025777ONEKUBEDDESIGNS1Y2026-01-017501 E. State Highway 71 Building #8 Spicewood TX US 78669
30130589503013058950ONE LAMBDA, INC1N2026-01-01Neuendorfstr. 25 room 03.206 Hennigsdorf Brandenburg DE 16761
30135511633013551163ONE DIRECT HEALTH1N2026-01-012270 Northwest Pkwy. SE #160 Marietta GA US 30067
30152162643015216264One-AI Healthcare, Inc1Y2026-01-0114860 Ne 95th St Redmond WA US 98052
30175486453017548645Oneday Biotech Co., Ltd.1N2026-01-01135 C SEONGSEODONGRO DALSEOGU DAEGU KR 42721
30265725813026572581ONERA HEALTH INC.1Y2026-01-013500 S. Dupont Highway Dover DE US 19901
30275182633027518263ONEHALF DESIGN CO.,LTD1N2026-01-01302, Plant 2, No.8 Zidong Avenue, Tianqiao District Jinan Shandong CN 250000
30302285753030228575ONEPACS, LLC1N2026-01-018777 Velocity Drive Machesney Park IL US 61115
30374113063037411306ONEDAY BIOTECH1Y2026-01-011 W Forest Ave Ste 2d Englewood NJ US 07631
30423704993042370499ONENESS (USA) BIOTECH INC.1Y2026-01-0113800 Live Oak Ave Baldwin Park CA US 91706
30429534543042953454ONETOUCH MEDICAL, LLC1Y2026-01-0119005 Fm 529 Rd Ste 6f Cypress TX US 77433
30435858863043585886ONEPASS MEDICAL LTD1N2026-01-011st The Four street Katzrin Industrial Park Katzrin Northern IL 1290000
00ONE HUNDRED POINT MEDICAL TECHNOLOGY (WENZHOU) CO., LTD5N2020-04-25Qiaotou town Gulian Industrial Zone, Yongjia County Wenzhou Zhejiang CN 325700
10002957061000295706One World DMG1N2020-04-2530 Technology Dr WARREN NJ US 07059
30040077523004007752One Beat CPR Learning Center LLC1Y2020-04-254350 Oakes Road Ste 500-503 Davie FL US 33314
30085135083008513508ONEPACS, LLC1N2020-04-25530 Lytton Ave Fl 2 Palo Alto CA US 94301
30108971913010897191ONE STAR INTERNATIONAL1N2020-04-25A-1405, Song-do Smart Valley Songdomirae-ro 30 Yeonsu-gu Incheon Gwangyeogsiv KR 21990
30109156643010915664One Click Internet Ventures, LLC1Y2020-04-251300 Windhorst Way Ste A Greenwood IN US 46143
30109666993010966699ONEFIT MEDICAL1N2020-04-2518 rue Alain Savary BESANCON Doubs FR 25000
30141976643014197664ONE SURGICAL, INC.1N2020-04-2520 Dudley St Ste 300 Memphis TN US 38103
30145279683014527968ONE DIVERSIFIED, LLC1N2020-04-251801 Royal Lane Bldg. 10, Ste. 1000 Dallas TX US 75229

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3481332021212783K251542InstaFANODG2025-07-18
2799561446338447K231753Oneday Implant AbutmentNHA2024-02-21
2799561078976890K222946Oneday Mini Implant SystemDZE2023-08-23
2799561233092904K192294I DoDZE2020-07-31
3459381810224713K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single useFMF2019-09-12
1164931165364823K181460OnePacs SystemLLZ2018-10-11
3235331165364823K181460OnePacs SystemLLZ2018-10-11
1720261568041636K173390hipEOSLLZ2018-04-27
1993041690247145K170787Powered Wheelchair DYW30A(D09)ITI2017-08-09
1720261468420581K161828kneeEOSLLZ2016-10-03
1720261539539016K160407spineEOSLLZ2016-04-08
1720261407763190K142671ONEFIT HIP PLANNERLLZ2014-12-05
2140441332036482K131455RESTORE MODULAR STERILIZATION TRAY SYSTEMKCT2013-08-30
344651194980921BR220737
1954881194980921BR220737
344651530380678BK980015
1954881530380678BK980015
344651565410323BK960062
1954881565410323BK960062
344651372095189BK960053
1954881372095189BK960053
344651701652496BK960011
1954881701652496BK960011
344651056098459BK920009
1954881056098459BK920009
344651210966370BK840013
1954881210966370BK840013
344651666297326BK241074
1954881666297326BK241074
344651528142795BK200546
1954881528142795BK200546
344651737480108BK170053
1954881737480108BK170053
344651008683918BK160018
1954881008683918BK160018
344651948980100BK160017
1954881948980100BK160017
344651420325123BK140141
1954881420325123BK140141
344651251878099BK130009
1954881251878099BK130009
344651684301832BK120024
1954881684301832BK120024
344651595114070BK120014
1954881595114070BK120014
344651813891555BK110038
1954881813891555BK110038
344651612332259BK100068
1954881612332259BK100068
344651436012892BK080071
1954881436012892BK080071
344651481454884BK070070
1954881481454884BK070070
344651549859497BK070038
1954881549859497BK070038
344651890013156BK050071
1954881890013156BK050071
344651424376655BK050070
1954881424376655BK050070
344651316569068BK030069
1954881316569068BK030069
344651087283072BK030003
1954881087283072BK030003
344651800171450BK020068
1954881800171450BK020068
344651435896855BK020055
1954881435896855BK020055
344651781905232BK000019
1954881781905232BK000019
1164931011123545
1954881044057831
597041076053104
2459821116307142
597041153604836
2459821238333643
2183981248519653
2459821257749233
2058991304765323
1954881346325765
1702631408478107
1720261422233812
1954881523573357
2140441554203888
597041591623764
1954881747885943
2459821775781103
1702631801773148
597041921032014
1954881956184452
597041961428523
2266732061008285
3235331011123545
1560391013230722
2799561019830891
1806811023114260
344651044057831

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ62018-10-11
DZE22023-08-23
ODG12025-07-18
NHA12024-02-21
FMF12019-09-12
ITI12017-08-09
KCT12013-08-30

NDC#

Oxygen

One Home Medical Equipment, LLC

Oxygen

sumatriptan

ONESOURCE SPECIALTY PHARMA LIMITED

sumatriptan

sumatriptan

ONESOURCE SPECIALTY PHARMA LIMITED

sumatriptan

sumatriptan

ONESOURCE SPECIALTY PHARMA LIMITED

sumatriptan

sumatriptan

ONESOURCE SPECIALTY PHARMA LIMITED

sumatriptan

64 records. Showing 1-40. Next

PMN#

HipEOS

2018-04-27

OneFIT Medical

HipEOS

2016-06-28

ONEFIT MEDICAL

48 records. Showing 1-40. Next

Applications#