FDA.report

APPLE INC.

Matched from indexed company URL: Apple, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30143439543014343954APPLE INC.1N2026-01-01One Apple Park Way Cupertino CA US 95014
30079578423007957842Apple Biomedical Inc1N2020-04-258F, No.12, Lane 609 , Chong Shin Road, Sec. 5, SanChong Dist New Taipei City Taipei - Special Municip TW 24159
30123298873012329887APPLE TREE INTL CORP1Y2020-04-2510700 Business Dr Unit #200 Fontana CA US 92337

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2230041153812030K253582Medical Imaging Calibration Feature (MICF)SHN2026-04-01
2230041921451238K250507Hypertension Notification Feature (HTNF)SFR2025-09-11
2230041954038347K250143Digital Prism Correction Feature (DPCF)SCW2025-06-23
2230041683458831K240929Sleep Apnea Notification Feature (SANF)QZW2024-09-13
2230041659644433K213971Atrial Fibrillation History FeatureQDB2022-06-03
2230041522575507K212516IRNF AppQDB2021-10-22
2230041168764515K201525ECG AppQDA2020-10-08
2230041261814359DEN230081Hearing Aid Feature (HAF)SCR2024-09-12
2230041943039950DEN180044ECG AppQDA2018-09-11
2230041400348829DEN180042Irregular Rhythm Notification FeatureQDB2018-09-11
1091791183737132
1091791285880403
1091791364555612
1091791399714504
1091791501659287
1091791621161695
1091791778059727
2230041281220090
2230041823429605
2230041973503452
2230042055753249

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
QDB32022-06-03
QDA22020-10-08
SHN12026-04-01
SFR12025-09-11
SCW12025-06-23
QZW12024-09-13
SCR12024-09-12

PMN

GUDID