Product Code: FMI


Products Classified as FMI

2552Needle, Hypodermic, Single LumenHypodermic Single Lumen Needle.

Total Product Life Cycle (TPLC) Devices

2552Needle, Hypodermic, Single LumenHypodermic Single Lumen Needle.

FDA Consensus Standards

Needle, Hypodermic, Single Lumen [31768]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [33892]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [30206]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [30511]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [37194]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [37192]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [37193]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [33873]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [34429]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [34431]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [35740]21 CFR §880.5570 🔎
Needle, Hypodermic, Single Lumen [34430]21 CFR §880.5570 🔎

Pre-market Notifications for FMI

K223353DropSafeTM SicuraTMPikdare SpA
K222124Sterile Hypodermic Syringe With/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd
K221176Insulin Pen NeedleTianjin Huahong Technology Co., Ltd.
K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.
K220614MEDOJECT Fine Pen NeedlesChirana T. Injecta
K213535Sterile Safety Hypodermic Needles For Single UseZhejiang Kangkang Medical-Devices CO., Ltd.
K213407UltiCare Disposable Pen NeedlesUltiMed Incorporated
K213183Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co. Ltd
K213156BD Nano 2nd Gen Pen NeedleBecton, Dickinson And Company
K212805SteriCap Mini Needle And Standard NeedlesOcuJect, LLC
K212514Safety Pen Needle For Single Use, Insulin Pen NeedlesBerpu Medical Technology Co., Ltd.
K212095SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V.
K212015BD Nano 2nd Gen Pen NeedleBecton Dickinson And Company
K211968NIO+ AdultWaisMed Ltd
K211716DropSafe Safety Pen NeedlesHTL STREFA SA

Global Unique Device Identification Database

00384703890039Needle, Hypodermic, Single Lumen
00384703860032Needle, Hypodermic, Single Lumen
00384703850019Needle, Hypodermic, Single Lumen
00384703840010Needle, Hypodermic, Single Lumen
00384703830035Needle, Hypodermic, Single Lumen
00384703829039Needle, Hypodermic, Single Lumen
00384703595033Needle, Hypodermic, Single Lumen
00384703590014Needle, Hypodermic, Single Lumen
00384703560017Needle, Hypodermic, Single Lumen
00384703550018Needle, Hypodermic, Single Lumen
00384703540033Needle, Hypodermic, Single Lumen
00384703530010Needle, Hypodermic, Single Lumen
00384703529038Needle, Hypodermic, Single Lumen
00384703490017Needle, Hypodermic, Single Lumen
00384703450011Needle, Hypodermic, Single Lumen

Maude Adverse Events

PEN NEEDLE 31X8 ASIABD (SUZHOU)2020-03-31
BD VACUTAINER? PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDERBECTON, DICKINSON & CO., (BD)2020-03-31
CAREONEUNK2020-03-30
CAREONEUNK2020-03-30
BD ULTRA-FINE? PEN NEEDLEBECTON DICKINSON AND CO.2020-03-30
UNSPECIFIED BD PEN NEEDLEBECTON DICKINSON2020-03-26
UNSPECIFIED BD? PEN NEEDLEBECTON DICKINSON2020-03-26
UNSPECIFIED BD PEN NEEDLEBECTON DICKINSON2020-03-26
WINGED INFUSION SET 20G X 1 INBARD ACCESS SYSTEMS2020-03-26
EZ-IO POWER DRIVERTELEFLEX MEDICAL2020-03-25
NEEDLE 30G X 1/2" 30MG/MLUNK2020-03-24
NEEDLE 30G X 1/2" 30MG/MLUNK2020-03-24
BD ULTRA FINE? PEN NEEDLESBECTON, DICKINSON AND CO.2020-03-24
DROPSAFEHTL-STREFA S.A.2020-03-24
DROPLETHTL-STREFA S.A.2020-03-24
PEN NEEDLES FGTRIVIDIA HEALTH INC2020-03-24
MONOJECTCARDINAL HEALTH, INC.2020-03-24
MONOJECTCARDINAL HEALTH, INC.2020-03-24
MAGELLANCARDINAL HEALTH, INC.2020-03-24
BD VACUTAINER? ECLIPSE? BLOOD COLLECTION NEEDLEBECTON, DICKINSON & CO., (BD)2020-03-23
EZ-IO POWER DRIVERTELEFLEX MEDICAL2020-03-23
EZ-IO POWER DRIVERTELEFLEX MEDICAL2020-03-23
N/ANEEDLE, HYPODERMIC, SINGLE LUMENBECTON, DICKINSON AND COMPANY2020-03-23
BD PRECISIONGLIDE? NEEDLEBD MEDICAL (BD WEST) MEDICAL SURGICAL2020-03-20
NEEDLE 26X3/8 IBBD MEDICAL (BD WEST) MEDICAL SURGICAL2020-03-20
BD ULTRA-FINE? NANO? PEN NEEDLES 4MM (5/32?) 32GBECTON DICKINSON AND CO.2020-03-20
PN 32X4 EUROPE BDBECTON DICKINSON AND CO.2020-03-20
SAFETY NEEDLE 25 X 5 8COVIDIEN2020-03-20
PEN NDL 31G 6MM 3B TWBECTON DICKINSON AND CO.2020-03-20
NEEDLE ECLIPSE 23X1 RBBECTON DICKINSON MEDICAL (SINGAPORE)2020-03-20
PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPXBECTON DICKINSON AND CO.2020-03-20
PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPXBECTON DICKINSON AND CO.2020-03-20
UNSPECIFIED BD NEEDLEBECTON DICKINSON2020-03-20
BD PRECISIONGLIDE? NEEDLEBD MEDICAL (BD WEST) MEDICAL SURGICAL2020-03-20
BD SAFECLIP?BECTON DICKINSON2020-03-19
PEN NEEDLE 32GX4MM 14 PACKBD (SUZHOU)2020-03-19
PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLYBECTON DICKINSON AND CO.2020-03-19
PN 31X8BECTON DICKINSON AND CO.2020-03-19
BD ULTRA-FINE? NANO? PEN NEEDLES 4MM (5/32?) 32GBECTON DICKINSON AND CO.2020-03-19
PN 31X5 FRANCE 5BBECTON DICKINSON AND CO.2020-03-19
BD? SHARPS COLL CHEMO 19GAL YELLOWBECTON DICKINSON2020-03-19
BD MICROLANCE? NEEDLEBECTON DICKINSON, S.A.2020-03-19
EZ-IO POWER DRIVERTELEFLEX MEDICAL2020-03-19
PN 32GX4MM ENGLISHBECTON DICKINSON AND CO.2020-03-19
NEEDLE (PEN NEEDLE DISPOSABLE)UNKNOWN2020-03-18
UNSPECIFIED BD? NEEDLEBECTON DICKINSON2020-03-18
NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EUROBD MEDICAL (BD WEST) MEDICAL SURGICAL2020-03-18
UNSPECIFIED BD NEEDLEBECTON DICKINSON2020-03-18
UNSPECIFIED BD? PEN NEEDLEBECTON DICKINSON2020-03-18
UNSPECIFIED BD PEN NEEDLEBECTON DICKINSON2020-03-18

© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.