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FUJIFILM Healthcare Americas Corporation

13 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Synapse PACS (7.6.0) (K261713)FUJIFILM Healthcare Americas Corporation2026-06-18
FUJIFILM Stiffening Wire Device (SW-2000) (K251204)FUJIFILM Healthcare Americas Corporation2025-09-26
Synapse PACS (7.5) (K243647)FUJIFILM Healthcare Americas Corporation2025-06-30
Double Balloon Endoscope EN-840T, Over-tube TS-1214C (K233321)FUJIFILM Healthcare Americas Corporation2024-06-13
APERTO Lucent MRI System (K233629)FUJIFILM Healthcare Americas Corporation2024-05-10
ECHELON Synergy V10.0 (K233687)FUJIFILM Healthcare Americas Corporation2024-05-03
FCT iSTREAM Phase 1 (K233583)FUJIFILM Healthcare Americas Corporation2024-04-26
FUJIFILM Endoscope Model EB-710XT (K240075)FUJIFILM Healthcare Americas Corporation2024-02-07
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (K231666)FUJIFILM Healthcare Americas Corporation2023-12-13
ARIETTA x10 (K231941)FUJIFILM Healthcare Americas Corporation2023-11-20
Scenaria View 4.2 (K231574)FUJIFILM Healthcare Americas Corporation2023-10-12
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) (K230752)FUJIFILM Healthcare Americas Corporation2023-09-15
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) (K232314)FUJIFILM Healthcare Americas Corporation2023-09-01

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Every clearance here is in the API, with alerts when new ones post.