Product code FMF— General Hospital
Merit Syringe
- Classification name
- Syringe, Piston
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Total cleared
- 756
- First cleared
- Most recent
Market context for product code FMF
FDA has cleared devices under product code FMF between 1976 and 2026, filed by 456 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code FMF
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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 FMF
1–100 of 756- K262581 — GraftGun Universal Graft Delivery System (GDS®)
- K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
- K260208 — Ultra-Fine SAFETY Insulin Syringe
- K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
- K253112 — Sofjec (3 models)
- K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
- K253068 — Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
- K253769 — Instylla Delivery Kit
- K252518 — DuoprossTM Smart Cap (Type I)
- K251089 — EXEL Disposable Syringe +3 more
- K250192 — Verisafe Safety Retractable Insulin Syringes
- K250853 — Merit Syringe
- K250510 — Sure-Fine Insulin Syringes
- K243660 — Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777) +8 more
- K251350 — BD Plastipak Syringe
- K252033 — Profoject Disposable Syringe, Profoject Disposable Syringe with Needle
- K250733 — 3DOSE 1ml Syringe
- K251648 — GPS Advanced; GPS Advanced Cannula
- K250262 — GO-PEN®
- K243580 — GraftGun Universal Graft Delivery System (GDS)
- K242434 — Insulin Syringes
- K241856 — Sofjec (3 models)
- K242099 — Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle
- K241821 — Luer Lock Syringe with Safety Needle +2 more
- K231095 — Tamper Evident Cap
- K240961 — Disposable Pen Injector Assembly
- K241426 — GPS Advanced; 5 cc GPS Advanced Cannula
- K233368 — Allograft Delivery Device (OFAC-C)
- K240774 — Pen Injector
- K232950 — Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
- K234024 — HWJECT Auto-disable syringe
- K233794 — Insulin Syringe
- K230235 — Medline Luer Lock Syringes
- K231558 — SMB Luer lock disposable syringe
- K230061 — Insulin Syringe
- K231877 — NavaClick Injection System
- K231519 — Revital Cady
- K233056 — EpiZact
- K221777 — Disposable Sterile Syringe
- K231792 — VeriSafe Safety sterile syringes
- K231888 — BD Texium Needle-Free Syringe
- K231727 — Sterile Auto-Disable Syringes with/without Needle for Single Use
- K231900 — A-TAP (previously called Arthrotap)
- K222925 — Hypodermic Syringes & Needle
- K231456 — Avitus® DragonWing Large Volume Autograft Delivery System
- K230492 — Avitus® Precision Autograft Delivery System
- K212857 — Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
- K220713 — Sol-Guard Auto-disable Syringe
- K221974 — EpiFinder
- K212207 — Sterile Hypodermic Syringe for Single Use
- K222672 — Disposable Insulin Syringe
- K223453 — Insulin Syringe
- K221702 — CompuFlo Epidural Computer Controlled Anesthesia System
- K212635 — Sofjec
- K203211 — Insulin syringe with integrated needle DL
- K223678 — Sterile Syringes for Single Use
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
- K212764 — Medwell Technology Ltd Syringes, various sizes
- K221045 — Insulin Syringes without needle
- K221308 — Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
- K222744 — Sol-M Luer Lock Syringe
- K221068 — Sterile Hypodermic Syringes for Single Use with Needles
- K221079 — Sterile Hypodermic Syringes for Single Use
- K212846 — Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
- K212033 — Disposable Sterile Syringe, with/without needle +1 more
- K221737 — InstaFill Graft Delivery System, SIGNIFY Bioactive
- K213158 — Syringe with permanently attached needle
- K220184 — Pump Alignment Syringe
- K220204 — Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
- K213811 — Sterile Hypodermic Syringes for Single Use
- K212677 — aboNT SYRINGE
- K213560 — Verifine Safety Syringe with Fixed Needle
- K203738 — Qitexio
- K212920 — Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
- K212499 — BD Insulin Syringe (0.3mL)
- K210848 — Sure-Fine Insulin Syringes
- K213632 — Instylla Delivery Kit
- K211210 — Sterile Auto-Disable Syringes with/without Needle for Single Use
- K211482 — Disposable Syringe with Needle
- K201044 — CHIRANA Insulin Syringes
- K210914 — Sterile Syringe for Single Use
- K212544 — MiniLoad Syringe
- K211211 — Sterile syringes for single use with/without needle
- K211728 — Sterile hypodermic syringes for single use
- K210818 — TrueCare Biomedix Tamper Evident Cap
- K210227 — Sterile syringe for single use with/without needle
- K211242 — Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
- K210712 — Verifine Mechanical Safety Insulin Syringe
- K210997 — PreferX Delivery System
- K210991 — Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
- K210464 — Auto Disable Syringe
- K203359 — BD Flu+ Syringe
- K210103 — SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
- K210200 — 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
- K203264 — MicroDose Injector
- K202432 — MiniLoad Syringe
- K203453 — BD Hypodermic Syringe
- K201930 — Nanum Syringe
Data sourced from openFDA. This site is unofficial and independent of the FDA.