Terumo Corporation

FDA Regulatory Profile

Terumo Corporation appears in FDA public data with 0 recalls, 13 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Mar 27, 2026.

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252295RyureiMar 27, 2026
K250700Pen Injector Needle 32.5Nov 21, 2025
K250751DualView CatheterJul 17, 2025
K240818R2P Radifocus Glidewire AdvantageNov 26, 2024
K240859Glidewire GT-RAug 21, 2024
K190427ImmuciseJul 18, 2019
K181369Immucise Intradermal Injection SystemNov 13, 2018
K173799NaviCross 0.018Mar 29, 2018
K170417Glidewire GTSep 15, 2017
K130280CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIRMar 13, 2013
K130493CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIRMar 13, 2013
K122544TERUMO SURFLASH SAFETY I.V. CATHETERSep 5, 2012
K113335HEARTRAIL III GUIDING CATHETERJul 16, 2012