Product code FMI— General Hospital
Sterile Hypodermic Needles for Single Use
- Classification name
- Needle, Hypodermic, Single Lumen
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Total cleared
- 695
- First cleared
- Most recent
Clearances under product code FMI — page 5
401–500 of 695- K970547 — ISOLYSER SDS SHARPS CONTAINER
- K970383 — SHARPS CONTAINER
- K970398 — SHARPS CONTAINER
- K963748 — BIO-PLEXUS DROP-IT NEEDLE HOLDER
- K964042 — EXTRESAFE PHLEBOTOMY
- K963571 — VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
- K970380 — F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM
- K970370 — TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
- K964654 — BECTON DICKINSON BLUNT PLASTIC CANNULA
- K970737 — B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
- K963351 — LIFESHIELD BLUNT CANNULA
- K965248 — BEMIS TWO GALLON SHARPS CONTAINER
- K963830 — SHARPS CONTAINER MODEL# SC001
- K962001 — MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
- K963595 — SERAGARD VASCULAR ACCESS DEVICE
- K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA
- K950686 — I.V. START KIT
- K962149 — SAFETY CRADLE
- K960933 — BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
- K961877 — PISTON SYRINGE
- K955772 — CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
- K961088 — NON-CORING NEEDLE
- K961251 — PUNCTUR-GUARD WINGED SET
- K961878 — SHARPS-TAINER
- K962035 — GE STERILE ARTHROGRAM TRAY
- K962040 — RNS ARTHROGRAM TRAY
- K961328 — BEC SHROUDED PLASTIC CANNULA
- K932889 — PERRY SPECIALTIES DESIGNS NEEDLE GUARD
- K960641 — RECAP-1
- K960963 — CORD WRAP WITH NEEDLE RESHEATHER
- K960698 — NON-CORING NEEDLE
- K955748 — DOYLE EXTRACTOR
- K942073 — SHARPSPRO-TECTOR
- K952044 — INSULCAP
- K955235 — B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
- K952837 — DARWIN HYPODERMIC SAFETY SYSTEM (DHSS)
- K954500 — HOSPITEC MEDI-BUTLER
- K940645 — KEY-LOK(TM) SYSTEM
- K935916 — LIP GRIP CAP HOLDER
- K954041 — G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)
- K951254 — SAFETYGLIDE NEEDLE
- K952834 — SHROUDED PLASTIC CANNULA
- K944931 — BECTON DICKINSON BLUNT STEEL CANNULA
- K952274 — CHEMOGUARD, P2 HIRISK
- K950012 — DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES
- K952518 — SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE
- K934435 — CAP-STIK
- K943057 — CAP SAFE SYSTEM
- K942930 — CAPCARD
- K943765 — SHARPS AWAY
- K946289 — DEVONS POINT LOK NEEDLE PROTECTION DEVICE
- K951736 — LOCK-UP
- K950899 — LABORATORY SHARPS BARREL
- K943626 — ISOLYSER SHARPS MANAGEMENT SYSTEM SMS
- K946041 — CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.)
- K951515 — MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER
- K946084 — VANGUARD
- K950466 — B-D ULTRA-FINE II PEN NEEDLE
- K925056 — SAFESHARPE (TM) DISPOSAL SYSTEM
- K950159 — SURESHARP
- K945825 — SECURE SAFETY INSERT
- K945809 — MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
- K943771 — MEDX REUSABLE SHARPS CONTAINER
- K944680 — SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE
- K944121 — SHARPS CONTAINER 18 GALLON
- K941031 — TOHP-CAP
- K946027 — BIG PHIL
- K944757 — PISTON SYRINGES
- K945284 — TRUJECT
- K943740 — ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
- K943794 — MX4000
- K945273 — PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2
- K945274 — PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80
- K945275 — PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1
- K945276 — PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G
- K943679 — UNIVEC NONRESUSABLE LOCKING SYRINGE
- K942179 — PRO-TEC DISPOSABLE SHARPS CONTAINERS
- K943892 — POINT OF USE SHARPS A GATOR
- K944114 — PHLEBOTOMY UNIT SHARPS A GATOR
- K943139 — B-D GUARDIAN ONE PIECE SHARPS COLLECTORS
- K943722 — CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
- K943134 — B-D GUARDIAN NESTABLE SHARPS COLLECTORS
- K943135 — MED-SAFE INSULIN SHARPS CONTAINER
- K943136 — B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS
- K943137 — B-D/BFI MAIL DISPOSAL SERVICE
- K943140 — B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS
- K943141 — B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS
- K944230 — DIAL MEDICAL SUPPLY SHARPS CONTAINER
- K943683 — B-D SAFE-CLIP
- K943575 — B-D GUARDIAN NESTABLE SHARPS COLLECTORS
- K942901 — SHARPS-TAINER LARGE OPENING
- K942903 — SHARPS-TAINER SMALL OPENING
- K940961 — MONOJECT LUER ADAPTER
- K943485 — MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER
- K943496 — MONOJECT TRAY SIZE SHARPS CONTAINER
- K942624 — LOK-ON NEEDLE DISPOSAL CONTAINER
- K942937 — SHARPSAFE CAT NO. 4105, 4115 AND 4120
- K942054 — SHARPS-TAINER
- K943578 — MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER
- K943594 — BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.