FDA.reportPublic FDA data

IRIS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10002046381000204638Iris Pohl1N2026-01-014222 Emperor Blvd Suite 390 Durham NC US 27703
30028130513002813051IRIS USA INC1N2026-01-0111111 80th Ave Pleasant Prairie WI US 53158
30039743703003974370Iris Pohl1N2026-01-014222 Emperor Blvd Suite 390 Durham NC US 27703
30065372863006537286Iris Xi1N2026-01-018717 Research Dr Irvine CA US 92618
30076160623007616062IRIS BEAUTY SUPPLIES INC1N2026-01-0169 Brunswick DOLLARD-DES-ORMEAUX Quebec CA H9B 2N4
30172379153017237915IRISBOND CROWDBONDING, S.L.1N2026-01-01Avenida de Tolosa, 75 Planta 2 Donostia San Sebastian Guipuzcoa ES 20018
30254307893025430789Iris Xi1N2026-01-018717 Research Dr Irvine CA US 92618
30430482163043048216Iris + Arlo Inc.1N2026-01-01160 Saint Viateur Street East Suite 202 Montreal Quebec CA H2T1A8

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3427551227871221K230380Surgical Face Masks, Model: EFMDS-L50Pn BLUFXX2023-08-03
3463371907818593K211775Cohitech Organic Cotton Non-Applicator Cottonlock TamponsHEB2021-10-22
3463371286944397K182813COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHTHEB2019-03-15
2077061599735299K181537GLOW800IZI2018-09-07
2077061859721149K170239Leica FL560IZI2017-07-05
2077061052119132K141136LEICA FL800IZI2014-08-19
3463371438922823K091084MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONSHEB2009-04-29
2077061937301735K080612LEICA FL800IZI2008-05-09
2077061288582578K061871LEICA MODEL FL800IZI2006-09-20
2077061078539622DEN180024Leica FL400QFX2019-03-28
2077061046535217
2077111046535217
2478381428392762
2077061451388114
2077111451388114
2077061504060272
2077111504060272
2077111052119132
2077111078539622
979831093213148
2478381104031379
3111891132629846
3463371226667443
2077111288582578
2077111400504227
2077061400504227
3384031408118443
2077111599735299
3111891681968277
3463371686625678
2077111792579266
2077061792579266
3111891807612171
2077111859721149
2077111937301735
2077111960488439
2077061960488439

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IZI52018-09-07
HEB32021-10-22
FXX12023-08-03
QFX12019-03-28

NDC#

PMN#

CONDOM

1988-07-05

IRIS MEDICAL ENT., INC.

GUDID#

Irisbond - Oskol 2 is an Augmentative and Alternative Communication system. Oskol 2 provides a communication tool for people with oral communication difficulties, especially those with severe motor disabilities who cannot use conventional mouse-based systems. People with conditions such as Amyotrophic Lateral Sclerosis (ALS) or Cerebral Palsy can access various applications installed on the computer using Oskol 2. Oskol 2 is specifically designed for use with gaze interaction. It incorporates an eye tracker that estimates the point on the screen where the user is looking. This allows the on-screen pointer to move in time with the user's gaze, replacing traditional mouse or touch interactions. Augmentative and Alternative Communication (AAC) tools allow users to communicate effectively.

IRISBOND CROWDBONDING SL.

2025-08-01

48 records. Showing 1-40. Next