FDA.reportPublic FDA data

NEXUS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041945233004194523NEXUS MEDICAL, LLC1Y2026-01-0111315 STRANG LINE ROAD LENEXA KS US 66215
30060606853006060685NEXUS / CHILI GmbH1N2026-01-01FRIEDRICH-EBERT-STRASSE 2 DOSSENHEIM/HEIDELBERG Baden-Wurttemberg DE 69221
30070851133007085113NEXUS, INC.1N2026-01-013-403 Yanagimachi Sabae Fukui JP 916-0047
30097026713009702671NEXUS CMF1N2026-01-012825 E. Cottonwood Parkway Suite 330 Salt Lake City UT US 84121
30113907633011390763NEXUS SPINE, L.L.C.1N2026-01-012825 E COTTONWOOD PKWY STE 330 Salt Lake City UT US 84121
30182104893018210489NEXUS SPINE, LLC.1N2026-01-0113867 South Bangerter Parkway, Suite 150 Draper UT US 84020
30320002743032000274NEXUS DENTAL LAB, LLC1Y2026-01-01502 Sw 31st Pl Cape Coral FL US 33991
30081177423008117742NEXUS DX, INC.1N2020-04-256759 Mesa Ridge Road San Diego CA US 92121
30102316873010231687NEXUS GLOBAL DIRECT1Y2020-04-251257 Worcester Rd Suite 279 Framingham MA US 01701

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
614211422914848K890176EXTENSION SETS WITH AND WITHOUT FILTERSFPA1989-04-26
1791611542726134K253331PressON Spinal Fixation SystemNKB2025-10-14
3163481542726134K253331PressON Spinal Fixation SystemNKB2025-10-14
1791611506456307K243934Stable-L Lumbar Interbody SystemOVD2025-04-30
3163481506456307K243934Stable-L Lumbar Interbody SystemOVD2025-04-30
1791611078356315K241467Stable-C Interbody SystemOVE2024-07-17
3163481078356315K241467Stable-C Interbody SystemOVE2024-07-17
1791611673818776K240416Tranquil-C Interbody SystemODP2024-03-12
3163481673818776K240416Tranquil-C Interbody SystemODP2024-03-12
1791611655941046K233375Tranquil-L Interbody SystemMAX2024-03-20
3163481655941046K233375Tranquil-L Interbody SystemMAX2024-03-20
1791611053582735K233234PressON Spinal Fixation SystemNKB2023-10-26
3163481053582735K233234PressON Spinal Fixation SystemNKB2023-10-26
1791611613683214K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemOVD2023-09-18
3163481613683214K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemOVD2023-09-18
1791611047779472K231763Stable-C Interbody SystemOVE2023-08-21
3163481047779472K231763Stable-C Interbody SystemOVE2023-08-21
1791611653466695K231486Stable-L Standalone Lumbar Interbody SystemOVD2023-10-12
3163481653466695K231486Stable-L Standalone Lumbar Interbody SystemOVD2023-10-12
1791611944928497K223627PreView-III™ Anterior Cervical Plate SystemKWQ2023-02-02
3163481944928497K223627PreView-III™ Anterior Cervical Plate SystemKWQ2023-02-02
1791612037584597K223529PressON Spinal Fixation SystemNKB2023-05-02
3163482037584597K223529PressON Spinal Fixation SystemNKB2023-05-02
1791611744641544K212498Stable-L Standalone Lumbar Interbody SystemOVD2022-03-18
3163481744641544K212498Stable-L Standalone Lumbar Interbody SystemOVD2022-03-18
1791611407256907K181702Tranquil-L Interbody SystemMAX2018-09-21
3163481407256907K181702Tranquil-L Interbody SystemMAX2018-09-21
1791611778739749K181621Stable-C Interbody SystemOVE2018-10-19
3163481778739749K181621Stable-C Interbody SystemOVE2018-10-19
1791611516229094K181483Tranquil Interbody SystemMAX2018-08-27
3163481516229094K181483Tranquil Interbody SystemMAX2018-08-27
1791611347564169K170297Tranquil Interbody SystemMAX2017-06-27
3163481347564169K170297Tranquil Interbody SystemMAX2017-06-27
1791612061377690K160820PressON Pro Spinal Fixation SystemNKB2016-06-28
3163482061377690K160820PressON Pro Spinal Fixation SystemNKB2016-06-28
1791611351113153K133287PRESSON SPINAL FIXATION SYSTEMMNH2014-02-25
3163481351113153K133287PRESSON SPINAL FIXATION SYSTEMMNH2014-02-25
614211074697649K130879NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUSFPA2013-07-09
614211247830987K130416NEXUS TKO-6P LUER ACTIVATED DEVICEFPA2013-06-12
614211778854493K130023K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTORFPA2013-04-03
614211490349898K113398NEXUS TKO-6, LUER-ACTIVATED DEVICEFPA2012-04-18
614211662174451K092930NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCEDFPA2010-03-10
614211483858484K092527NEXUS INJECTION SITE, MODEL NIS-8FPA2010-02-04
614211431347682K092418ENTRACARE GASTROSTOMY FEEDING TUBEKNT2009-10-23
614211181701615K092382NEXUS PRESSURE RATED EXTENSION SETSFPA2010-04-26
614211300388349K081123NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETSFPA2008-11-14
614212033323968K080976NEXUS I.V. FLUID TRANSFER DEVICELHI2008-11-10
1385621738639945K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHRX2008-03-18
1791611045492874K073500ACTIVE ANTERIOR CERVICAL PLATE SYSTEMKWQ2008-07-03
3163481045492874K073500ACTIVE ANTERIOR CERVICAL PLATE SYSTEMKWQ2008-07-03
672211516367323K070796CHILI PACSLLZ2007-04-06
1791611526130732K062371PREVIEW ANTERIOR CERVICAL PLATE SYSTEMKWQ2006-12-04
3163481526130732K062371PREVIEW ANTERIOR CERVICAL PLATE SYSTEMKWQ2006-12-04
614211308162212K053129NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5FPA2005-12-08
614211722083907K053049ALARIS SAFETY MALE LUERFPA2006-01-12
614211091279963K041861NEXUS INTRAVENOUS TUBING SETS (NIVTS)FPA2004-11-26
614211785083788K041845NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4FPA2004-08-24
1791611026867374
1112951175761487
1385621201739066
1112951207398439
1385621216436262
1385621216873186
1112951364607922
1791611390760316
1385621426704263
1112951649078197
1112951668602605
1385621681265049
1112951728138503
1385621732465527
1112951749966257
1385621786812431
1791611809040381
1112951849872579
1112951864160826
1112951942227762
1112951985341521
3163481026867374
3255331068089223
3322121153246420
1385621253814939
3255331274999363
1385621296832805
1385621315185703
1385621364810814
614211377077933
3163481390760316
1385621401718084
3322121438398195
1791611498065144
3163481498065144
3322121602142407
1385621618167928
614211689405855
1385621797162918
3322121797955659
3163481809040381
1385621821127528
1385621888670877
3322121929308307
614211953656134
614212016609631

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA132013-07-09
MAX112024-03-20
NKB92025-10-14
OVD82025-04-30
KWQ82023-02-02
OVE72024-07-17
MNH32014-02-25
ODP22024-03-12
HRX22008-03-18
KNT12009-10-23
LHI12008-11-10
LLZ12007-04-06

NDC#

BACLOFEN

Nexus Pharmaceuticals LLC

Baclofen

Emerphed

Nexus Pharamaceuticals Inc.

Ephedrine Sulfate

Emerphed

Nexus Pharmaceuticals, LLC

Ephedrine Sulfate

Emerphed

Nexus Pharmaceuticals, LLC

Ephedrine Sulfate

PMA#

PMN#

EVACU SLED

1991-12-04

NEXUS HEALTH CARE PRODUCTS LTD.

Applications#

GUDID#

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