Needle, Hypodermic, Single Lumen
FDA product code FMI · 670 cleared devices
Class 2
General Hospital
- Regulation
- 21 CFR 880.5570
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-16 – 2026-09-17
FMI
2026-09-17
FMI
2026-08-25
Promisemed X-Safety Pen Needle
View details →
FMI
2026-08-10
Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)
View details →
FMI
2026-08-07
Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
View details →
FMI
2026-07-29
Profoject™ Dual-Safety Pen Needles
View details →
FMI
2026-07-15
Profoject™ Pen Needles (Model A; Model B)
View details →
FMI
2026-06-10
Profoject™ Safety Pen Needles
View details →
FMI
2026-04-16
Verisafe Safety Sterile Needles (SSN)
View details →
FMI
2026-03-25
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
View details →
FMI
2026-03-24
PRESSONE™
View details →
FMI
2026-03-18
Safety Pen Needle
View details →
FMI
2026-01-06
Pen Needle
View details →
FMI
2025-11-21
Pen Injector Needle 32.5
View details →
FMI
2025-10-16
Profoject™ Disposable Needle
View details →
FMI
2025-07-30
Intraosseous Infusion Needles
View details →
FMI
2025-07-24
TSK SELECT™ Needle
View details →
FMI
2025-07-08
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
View details →
FMI
2025-05-29
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
View details →
FMI
2025-04-18
FROG (Filter Removal of Glass)
View details →
FMI
2025-04-04
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
View details →
FMI
2025-04-03
SureFine Pen Needle
View details →
FMI
2025-01-10
Safety Winged Blood Collection Sets
View details →
FMI
2025-01-08
ACE Cannula
View details →
FMI
2024-09-26
Verifine® Pen Needles
View details →
FMI
2024-07-02
ZIEN IO Intraosseous Access System
View details →
FMI
2024-02-01
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
View details →
FMI
2023-12-12
Sterile Hypodermic Needles for Single Use
View details →
FMI
2023-11-27
SteriCap Safety Needle; VitreJect Safety Needle
View details →
FMI
2023-10-05
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®
View details →
FMI
2023-09-20
Insulin Pen Needle
View details →
FMI
2023-09-14
VitreJect® Needle; OcuSafe® Needle
View details →
FMI
2023-09-08
Sterile syringes for single use with/without needle
View details →
FMI
2023-09-08
Sterile Safety Hypodermic Needles for Single Use
View details →
FMI
2023-09-08
Sterile Hypodermic Needles for Single Use
View details →
FMI
2023-08-25
NovoFine® Plus
View details →
FMI
2023-07-27
Altaviz Needle Kit II
View details →
FMI
2023-07-25
EZ-IO Intraosseous Vascular Access System
View details →
FMI
2023-06-02
Pen Needle
View details →
FMI
2023-05-25
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
View details →
FMI
2023-04-06
Disposable Insulin Pen Needle
View details →
FMI
2023-03-20
Shina Safety Needle
View details →
FMI
2023-02-16
Sterile Aesthetic Cannula and Hypodermic Needle
View details →
FMI
2023-02-15
Verisafe Safety sterile needles
View details →
FMI
2023-01-20
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
View details →
FMI
2022-12-28
BD AutoShield Duo™ Pen Needle
View details →
FMI
2022-12-16
Sterile Hypodermic Needles for Single Use
View details →
FMI
2022-12-13
CCBIO ASCPO Needle
View details →
FMI
2022-12-05
Altaviz Needle Kit
View details →
FMI
2022-12-02
DropSafeTM SicuraTM
View details →
FMI
2022-11-17
Disposable Insulin Pen Needle
View details →
FMI
2022-11-04
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
View details →
FMI
2022-10-31
IO Needle Safety Sheath
View details →
FMI
2022-10-14
Safety Insulin Pen Needles
View details →
FMI
2022-10-04
Sterile Safety Hypodermic Needles for Single Use
View details →
FMI
2022-10-04
Sterile Hypodermic Needles for Single Use
View details →
FMI
2022-09-19
Promisemed X-Safety Pen Needle
View details →
FMI
2022-08-23
Disposable Medical Safety Hypodermic Needle
View details →
FMI
2022-08-22
SurGuard3 Safety Hypodermic Needle
View details →
FMI
2022-07-01
Insulin Pen Needle
View details →
FMI
2022-06-28
BD Pen Needle
View details →
FMI
2022-06-15
MEDOJECT fine Pen Needles
View details →
FMI
2022-05-25
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
View details →
FMI
2022-05-13
Sterile Safety Hypodermic Needles for Single Use
View details →
FMI
2022-04-29
Safety Pen Needle for Single Use, Insulin Pen Needles
View details →
FMI
2022-04-12
Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
View details →
FMI
2022-02-17
Safety Pen Needle
View details →
FMI
2022-01-07
DropSafe Safety Pen Needles
View details →
FMI
2021-12-16
UltiCare Disposable Pen Needles
View details →
FMI
2021-12-14
Blood Collection Needles
View details →
FMI
2021-12-08
BD Nano 2nd Gen Pen Needle
View details →
FMI
2021-11-19
BD Nano 2nd Gen Pen Needle
View details →
FMI
2021-11-12
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
View details →
FMI
2021-10-14
Sterile Hypodermic Needles for Single Use
View details →
FMI
2021-09-30
SteriCap Mini Needle and Standard Needles
View details →
FMI
2021-09-23
Sterile Hypodermic Needles for Single Use
View details →
FMI
2021-09-17
Unifine SafeControl
View details →
FMI
2021-08-26
Hypodermic Needle-Pro EDGE Safety Device
View details →
FMI
2021-07-28
NIO-I
View details →
FMI
2021-07-22
NIO+ Adult
View details →
FMI
2021-07-21
Promisemed Insulin Pen Needle
View details →
FMI
2021-06-25
Safety Winged Blood Collection Sets
View details →
FMI
2021-06-23
NovoFine
View details →
FMI
2021-04-22
Verifine Safety Type Insulin Pen Needle
View details →
FMI
2021-03-22
EZ-IO Intraosseous Vascular Access System
View details →
FMI
2021-02-02
Easydrip Pen Needle, Easydrip Plus Pen Needle
View details →
FMI
2020-12-31
Promisemed Covered Safety Pen Needle
View details →
FMI
2020-12-19
NovoFine Plus 32G Tip x 4 mm
View details →
FMI
2020-11-24
Promisemed Triple Safety Pen Needle
View details →
FMI
2020-11-05
Eclipse DermaFlex Cannula
View details →
FMI
2020-10-15
Droplet Pen Needle 30G & 33G
View details →
FMI
2020-08-25
Injection Pen Needle
View details →
FMI
2020-08-06
TK Safety Needle
View details →
FMI
2020-05-12
EZ-Inject Single use Needle
View details →
FMI
2020-04-21
Droplet Pen Needle 34G
View details →
FMI
2020-02-03
Bella-mu
View details →
FMI
2019-12-19
TK Sterile Hypodermic Needle
View details →
FMI
2019-11-21
SAM IO Intraosseous Access System
View details →
FMI
2019-11-13
Piper GO-IO Intraosseous Infusion System
View details →
FMI
2019-10-23
Intraosseous infusion device
View details →
FMI
2019-10-11
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
View details →No matching devices.
Advertisement