FMFFDA Class 2 · 21 CFR 880.5860
Syringe, Piston
Device family · General Hospital
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
745
Manufacturers
134
Flagged signals
17
Adverse-event reports
43,467
Code matrix
| FDA product code | FMF |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| GMDN | 32940 |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2016 | 35 | 582.4 | 19,747 |
| Other | 2015 | 3 | 399.0 | 827 |
| Other | 2011 | 3 | 95.0 | 193 |
| Other | 2013 | 4 | 91.7 | 274 |
| Other | 2016 | 3 | 24.0 | 45 |
| Other | 2016 | 6 | 10.0 | 40 |
| Other | 2014 | 14 | 9.9 | 104 |
| Other | 2011 | 12 | 9.2 | 80 |
| Other | 2024 | 4 | 7.6 | 17 |
| Other | 2013 | 10 | 7.1 | 47 |
| Other | 2016 | 6 | 5.6 | 19 |
| Other | 2013 | 3 | 5.3 | 7 |
| Other | 2012 | 3 | 5.0 | 6 |
| Other | 2012 | 5 | 3.8 | 8 |
| Other | 2010 | 5 | 3.8 | 8 |
| Other | 2012 | 5 | 3.6 | 7 |
| Injury | 2018 | 5 | 2.6 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 43,467 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 23 | 1998 | — |
| Sherwood Medical Co. | 20 | 1995 | — |
| Becton, Dickinson and Company | 13 | 2025 | — |
| Merit Medical Systems, Inc. | 10 | 2025 | — |
| Terumo Medical Corp. | 10 | 2007 | — |
| Abco Dealers, Inc. | 7 | 1988 | — |
| Promisemed Hangzhou Meditech Co., Ltd. | 7 | 2025 | — |
| Baxter Healthcare Corp | 6 | 2002 | — |
| Concord Laboratories, Inc. | 6 | 1981 | — |
| NIPRO MEDICAL CORPORATION | 6 | 2022 | — |
| Sol-Millennium Medical, Inc. | 5 | 2024 | — |
| B.Braun Medical, Inc. | 5 | 2020 | — |
| Biomet, Inc. | 4 | 2014 | — |
| SHINA MED CORPORATION | 4 | 2025 | — |
| ICU MEDICAL, INC. | 4 | 2008 | — |
| Instylla, Inc. | 4 | 2025 | — |
| Micromedics, Inc. | 4 | 2010 | — |
| PROCEDURE PRODUCTS, INC. | 4 | 2017 | — |
| TERUMO EUROPE N.V. | 4 | 2017 | — |
| PINNACLE SPINE GROUP, LLC | 3 | 2014 | — |
| Pharmacia, Inc. | 3 | 1995 | — |
| MEDLINE INDUSTRIES, INC. | 3 | 2022 | — |
| Wrightmedicaltechnologyinc | 3 | 2006 | — |
| ULTIMED, INC. | 3 | 2006 | — |
| Anhui Tiankang Medical Technology Co., Ltd. | 3 | 2022 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) · Chirana T.Injecta,A.S.510(k) · 2026-04-17
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe · CMT Health PTE., Ltd.510(k) · 2026-02-23
Instylla Delivery Kit · Instylla, Inc.510(k) · 2025-12-22
DuoprossTM Smart Cap (Type I) · Duopross Meditech Corporate510(k) · 2025-12-17
EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle · Exelint International, Co.510(k) · 2025-12-12
Verisafe Safety Retractable Insulin Syringes · Promisemed Hangzhou Meditech Co., Ltd.510(k) · 2025-12-10
Merit Syringe · Merit Medical Systems, Inc.510(k) · 2025-11-04
Sure-Fine Insulin Syringes · Shina Med Corporation510(k) · 2025-10-15
Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec · Cardinalhealth510(k) · 2025-08-22
BD Plastipak Syringe · Becton, Dickinson and Company510(k) · 2025-07-29
Profoject Disposable Syringe, Profoject Disposable Syringe with Needle · CMT Health PTE., Ltd.510(k) · 2025-07-25
3DOSE 1ml Syringe · Bimed Teknik Aletler Sanayi & Ticaret A.S.510(k) · 2025-07-03
GPS Advanced; GPS Advanced Cannula · Prosidyan, Inc.510(k) · 2025-06-24
GO-PEN® · Go-Pen Aps510(k) · 2025-04-24
GraftGun Universal Graft Delivery System (GDS) · SurGenTec, LLC510(k) · 2025-02-05
Insulin Syringes · Chirana T. Injecta510(k) · 2024-12-24
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) · Hlb Lifescience Co., Ltd.510(k) · 2024-12-23
Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle · Sol-Millennium Medical, Inc.510(k) · 2024-10-22
Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle · Sol-Millennium Medical, Inc.510(k) · 2024-09-20
Tamper Evident Cap · International Medical Industries, Inc.510(k) · 2024-09-04
Disposable Pen Injector Assembly · Wuxi Nest Biotechnology Co., Ltd.510(k) · 2024-08-15
GPS Advanced; 5 cc GPS Advanced Cannula · Prosidyan, Inc.510(k) · 2024-07-10
Allograft Delivery Device (OFAC-C) · Bioventus, LLC510(k) · 2024-06-25
Pen Injector · Wuxi Nest Biotechnology Co., Ltd.510(k) · 2024-06-18
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle · Perfect Medical Industry (Vn) Co., Ltd.510(k) · 2024-06-12
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.