FMI
Sterile Hypodermic Needles for Single Use
- Advisory panel
- General Hospital
- Total cleared
- 688
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FMI
1–100 of 688- K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
- K253047 — PRESSONE
- K253622 — Safety Pen Needle
- K252886 — Pen Needle
- K250700 — Pen Injector Needle 32.5
- K252631 — Profoject Disposable Needle
- K250724 — Intraosseous Infusion Needles
- K250284 — TSK SELECT Needle
- K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
- K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
- K240355 — FROG (Filter Removal of Glass)
- K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
- K250658 — SureFine Pen Needle
- K243806 — Safety Winged Blood Collection Sets
- K242741 — ACE Cannula
- K242632 — Verifine® Pen Needles
- K240915 — ZIEN IO Intraosseous Access System
- K232165 — Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
- K233037 — Sterile Hypodermic Needles for Single Use
- K233343 — SteriCap Safety Needle; VitreJect Safety Needle
- K230070 — MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®
- K230043 — Insulin Pen Needle
- K230959 — VitreJect® Needle; OcuSafe® Needle
- K231720 — Sterile Hypodermic Needles for Single Use
- K231723 — Sterile Safety Hypodermic Needles for Single Use
- K231729 — Sterile syringes for single use with/without needle
- K231255 — NovoFine® Plus
- K231261 — Altaviz Needle Kit II
- K231924 — EZ-IO Intraosseous Vascular Access System
- K230635 — Pen Needle
- K222852 — Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
- K222739 — Disposable Insulin Pen Needle
- K222417 — Shina Safety Needle
- K223327 — Sterile Aesthetic Cannula and Hypodermic Needle
- K222271 — Verisafe Safety sterile needles
- K203792 — Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
- K223286 — BD AutoShield Duo Pen Needle
- K223334 — Sterile Hypodermic Needles for Single Use
- K214004 — CCBIO ASCPO Needle
- K222681 — Altaviz Needle Kit
- K223353 — DropSafeTM SicuraTM
- K221178 — Disposable Insulin Pen Needle
- K222124 — Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
- K220890 — IO Needle Safety Sheath
- K213183 — Safety Insulin Pen Needles
- K221066 — Sterile Hypodermic Needles for Single Use
- K221080 — Sterile Safety Hypodermic Needles for Single Use
- K220129 — Promisemed X-Safety Pen Needle
- K220603 — Disposable Medical Safety Hypodermic Needle
- K212095 — SurGuard3 Safety Hypodermic Needle
- K221176 — Insulin Pen Needle
- K213478 — BD Pen Needle
- K220614 — MEDOJECT fine Pen Needles
- K210748 — Well-life TM Pen Needles, Well-life TM Safety Pen Needles
- K213535 — Sterile Safety Hypodermic Needles for Single Use
- K212514 — Safety Pen Needle for Single Use, Insulin Pen Needles
- K214075 — Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
- K210864 — Safety Pen Needle
- K211716 — DropSafe Safety Pen Needles
- K213407 — UltiCare Disposable Pen Needles
- K200932 — Blood Collection Needles
- K213156 — BD Nano 2nd Gen Pen Needle
- K212015 — BD Nano 2nd Gen Pen Needle
- K202319 — Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
- K211214 — Sterile Hypodermic Needles for Single Use
- K212805 — SteriCap Mini Needle and Standard Needles
- K210232 — Sterile Hypodermic Needles for Single Use
- K210399 — Unifine SafeControl
- K211634 — Hypodermic Needle-Pro EDGE Safety Device
- K211395 — NIO-I
- K211968 — NIO+ Adult
- K210059 — Promisemed Insulin Pen Needle
- K211293 — Safety Winged Blood Collection Sets
- K210258 — NovoFine
- K210065 — Verifine Safety Type Insulin Pen Needle
- K202492 — EZ-IO Intraosseous Vascular Access System
- K193422 — Easydrip Pen Needle, Easydrip Plus Pen Needle
- K202681 — Promisemed Covered Safety Pen Needle
- K202005 — NovoFine Plus 32G Tip x 4 mm
- K202682 — Promisemed Triple Safety Pen Needle
- K200017 — Eclipse DermaFlex Cannula
- K202340 — Droplet Pen Needle 30G & 33G
- K192464 — Injection Pen Needle
- K191644 — TK Safety Needle
- K192222 — EZ-Inject Single use Needle
- K192082 — Droplet Pen Needle 34G
- K192677 — Safety Insulin Pen Needle
- K190962 — Bella-mu
- K191643 — TK Sterile Hypodermic Needle
- K191488 — SAM IO Intraosseous Access System
- K191976 — Piper GO-IO Intraosseous Infusion System
- K191258 — Intraosseous infusion device
- K192057 — K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall
- K190538 — NIO-I
- K191853 — Dual-Safety Pen Needle
- K183016 — SteriCap Mini Needle
- K182770 — Adult Intraosseous Infusion Device
- K181447 — Safety insulin needle for single use
- K181730 — BD Vacutainer Eclipse UltraFill Blood Collection Needle
- K181508 — U&U Blood Collection Sets
Data sourced from openFDA. This site is unofficial and independent of the FDA.