← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

FMI — Needle, Hypodermic, Single Lumen

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5570
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
19
510(K)/PMA CLEARANCES
510k: 19
0
RECALL ENTRIES

Recent clearances

K260739CMT Health PTE., Ltd. · 510k2026-07-15
K260855CMT Health PTE., Ltd. · 510k2026-06-10
K254273Promisemed Hangzhou Meditech Co., Ltd. · 510k2026-04-16
K252908Sandstone Medical (Suzhou), Inc. · 510k2026-03-25
K253047Nipro Medical Corporation · 510k2026-03-24
K253622Ningbo Medsun Medical Co., Ltd. · 510k2026-03-18
K252886Hh Global Technology, Inc. · 510k2026-01-06
K250700Terumo Corporation · 510k2025-11-21

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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