FDA Product Code
FDA Product Code FMF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5860
510(k) Clearances — 752 records · page 2 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202544 | Instylla Delivery Kit | Instylla, Inc. | 2021-01-07 | Special | PDF ↗ |
| K193273 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2021-01-05 | Traditional | PDF ↗ |
| K192770 | S dispensing line | Aea Srl | 2020-12-17 | Traditional | PDF ↗ |
| K201284 | Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use | Set Medikal Sanayi VE Ticaret Anonim Sirketi | 2020-12-14 | Abbreviated | PDF ↗ |
| K201816 | ARTHROTAP | Accuro Technologies, Inc. | 2020-10-16 | Traditional | PDF ↗ |
| K201900 | 3D GraftRasp System | Surgentec | 2020-09-03 | Traditional | PDF ↗ |
| K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd | 2020-07-17 | Traditional | PDF ↗ |
| K201234 | BD SoloShot Mini Syringe/ BD Auto Disable Syringe | Becton, Dickinson and Company | 2020-07-15 | Traditional | PDF ↗ |
| K200325 | Orbit Subretinal Delivery System | Orbit Biomedical | 2020-07-14 | Traditional | PDF ↗ |
| K201338 | Allograft MIS Delivery System | Lifenet Health | 2020-07-13 | Traditional | PDF ↗ |
| K200629 | Aspire Mechanical Aspirator G | Control Medical Technology | 2020-05-29 | Special | PDF ↗ |
| K200431 | 3D GraftRasp System | Surgentec | 2020-05-18 | Traditional | PDF ↗ |
| K200606 | O-Genesis Graft Delivery System | Orthofix, Inc. | 2020-05-01 | Traditional | PDF ↗ |
| K193101 | Omnifix Low Dead Space Luer Lock Syringe | B.Braun Medical, Inc. | 2020-03-05 | Traditional | PDF ↗ |
| K192674 | Mixing and Delivery System | Bone Solutions, Inc. | 2020-02-18 | Traditional | PDF ↗ |
| K193192 | Tamper Evident Cap | International Medical Industries, Inc. | 2020-01-31 | Special | PDF ↗ |
| K191642 | TK Sterile Piston Syringe without Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2020-01-06 | Traditional | PDF ↗ |
| K190054 | BD Insulin Syringe | Becton, Dickinson and Company | 2019-10-21 | Traditional | PDF ↗ |
| K191659 | Instylla Delivery Kit | Instylla, Inc. | 2019-10-10 | Traditional | PDF ↗ |
| K191359 | Nipro Syringe | Nipro Medical Corporation | 2019-10-09 | Traditional | PDF ↗ |
| K192421 | EpiFaith Syringe | Flat Medical Co., Ltd. | 2019-09-27 | Special | PDF ↗ |
| K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use | Shanghai Kohope Medical Devices Co., Ltd. | 2019-09-12 | Traditional | PDF ↗ |
| K191531 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2019-09-06 | Special | PDF ↗ |
| K182765 | 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe | Top Corporation | 2019-09-03 | Traditional | PDF ↗ |
| K190996 | Bonus Therapeutics Mixing and Delivery System | Bonus Therapeutics , Ltd. | 2019-07-28 | Traditional | PDF ↗ |
| K190427 | Immucise | Terumo Corporation | 2019-07-18 | Traditional | PDF ↗ |
| K182268 | EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) | Flat Medical Co., Ltd. | 2019-04-05 | Traditional | PDF ↗ |
| K182589 | BD Plastipak Syringe | Becton, Dickinson and Company | 2019-03-14 | Traditional | PDF ↗ |
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. | 2018-12-17 | Traditional | PDF ↗ |
| K182274 | Orbit Subretinal Delivery System | Orbit Biomedical, Inc. | 2018-11-20 | Traditional | PDF ↗ |
| K182216 | Merit Syringe | Merit Medical Systems, Inc. | 2018-11-06 | Abbreviated | PDF ↗ |
| K182279 | Merit Syringe | Merit Medical Systems, Inc. | 2018-11-06 | Abbreviated | PDF ↗ |
| K172670 | BD Single Use, Hypodermic Syringe | Becton, Dickinson and Company | 2018-10-23 | Traditional | PDF ↗ |
| K180937 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2018-05-10 | Special | PDF ↗ |
| K173029 | Nipro Syringe | Nipro Medical Corporation | 2018-03-30 | Traditional | PDF ↗ |
| K173601 | Merit Syringe | Merit Medical Systems, Inc. | 2018-01-31 | Abbreviated | PDF ↗ |
| K173385 | Graft Delivery, DePuy Synthes | Micromedics, Inc. (D/B/A Nordson Medical) | 2017-11-30 | Special | PDF ↗ |
| K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories | Intervene Group, Ltd. | 2017-11-09 | Traditional | PDF ↗ |
| K171131 | MHC Standard and NRFit Tip Syringes | Mazza Healthcare, LLC | 2017-11-08 | Traditional | PDF ↗ |
| K171805 | Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml | Conceptomed AS | 2017-09-08 | Special | PDF ↗ |
| K171362 | Merit Syringe | Merit Medical Systems, Inc. | 2017-08-07 | Abbreviated | PDF ↗ |
| K170675 | Graftgun Universal Graft Delivery System | SurGenTec, LLC | 2017-07-19 | Traditional | PDF ↗ |
| K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2017-06-09 | Traditional | PDF ↗ |
| K170386 | BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle and BD Insulin Syringes with Micro-Fine IV Needle | Becton Dickinson & Company | 2017-04-12 | Special | PDF ↗ |
| K161812 | Freedom Syringe | Procedure Products, Inc. | 2017-03-27 | Abbreviated | PDF ↗ |
| K163161 | Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 | Traditional | PDF ↗ |
| K170218 | Vesco Medical NRFit Tip Syringes | Vesco Medical, LLC | 2017-02-24 | Traditional | PDF ↗ |
| K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | Terumo Europe N.V. | 2017-02-10 | Traditional | PDF ↗ |
| K162057 | ConceptoMed Luer-Jack Slip 10ml | Conceptomed AS | 2017-01-11 | Traditional | PDF ↗ |
| K162180 | Disposable Insulin Syringe | Berpu Medical Technology Co., Ltd. | 2016-12-29 | Traditional | PDF ↗ |
| K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe | Becton, Dickinson and Company | 2016-12-19 | Traditional | PDF ↗ |
| K162602 | NovoPen Echo | Novo Nordisk, Inc. | 2016-10-18 | Special | PDF ↗ |
| K161568 | Bone Solutions Mixing and Delivery System | Bone Solutions, Inc. | 2016-09-16 | Traditional | PDF ↗ |
| K152879 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2016-09-09 | Traditional | PDF ↗ |
| K160629 | InPen | Companion Medical, Inc. | 2016-07-26 | Traditional | PDF ↗ |
| K152803 | SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE | Sung Shim Medicare Co., Ltd. | 2016-07-12 | Traditional | PDF ↗ |
| K151870 | BD U-500 INSULIN SYRINGE | Becton, Dickinson and Company | 2016-07-08 | Traditional | PDF ↗ |
| K160978 | LITe BIO Delivery System | Stryker Corporation | 2016-07-08 | Traditional | PDF ↗ |
| K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | Sol-Millennium Medical, Inc. | 2016-06-17 | Traditional | PDF ↗ |
| K160668 | HumaPen Savvio | Eli Lilly and Company, Inc. | 2016-06-03 | Traditional | PDF ↗ |
| K153553 | SiO2 Coated syringe 3 ml | Sio2 Medical Products | 2016-05-17 | Traditional | PDF ↗ |
| K151686 | HumanPen Ergo II | Eli Lilly and Company, Inc. | 2015-12-30 | Traditional | PDF ↗ |
| K152783 | Merit 20 mL Syringe | Merit Medical Systems, Inc. | 2015-12-07 | Special | PDF ↗ |
| K151777 | Intradermal Adapter | West Pharmaceutical Services, Inc. | 2015-09-29 | Traditional | PDF ↗ |
| K151766 | BD Single Use, Hypodermic Syringe | Becton, Dickinson and Company | 2015-09-02 | Special | PDF ↗ |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. | 2015-07-31 | Special | PDF ↗ |
| K151543 | Graft Delivery Device with Integrated Stylet | Micromedics, Inc. (D/B/A Nordson Medical) | 2015-07-07 | Special | PDF ↗ |
| K142518 | HumaPen Luxura | Eli Lilly and Company | 2015-06-05 | Traditional | PDF ↗ |
| K142535 | ConMed Mixing and Delivery Kit | Conmed Corporation | 2015-04-23 | Traditional | PDF ↗ |
| K143757 | ANUTRA Feedback Aspiration Syringe | Anutra Medical, Inc. | 2015-01-08 | Traditional | PDF ↗ |
| K143488 | InFill Graft Delivery System | Pinnacle Spine Group, LLC | 2014-12-17 | Special | PDF ↗ |
| K142661 | Bi-Portal Bone Graft Delivery Device | Spinal Surgical Strategies, LLC | 2014-12-11 | Traditional | PDF ↗ |
| K142636 | Merit 10mL Syringe | Merit Medical Systems, Inc. | 2014-10-17 | Special | PDF ↗ |
| K140710 | BIOMET GRAFT DELIVERY SYRINGES | Biomet Spine (Aka Ebi, LLC) | 2014-09-04 | Traditional | PDF ↗ |
| K141762 | PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM | Biomet, Inc. | 2014-08-27 | Traditional | PDF ↗ |
| K141245 | ETEX MIXING AND DELIVERY SYSTEM | Etex Corporation | 2014-07-09 | Traditional | PDF ↗ |
| K140194 | NAMIC RCS SYRINGE | Navilyst Medical, Inc. | 2014-04-14 | Abbreviated | PDF ↗ |
| K133493 | SINGLE USE STERILE SYRINGE WITH NEEDLE | Jiangxi Kelun Medical Devices Manufacturing Co.,Lt | 2014-03-27 | Abbreviated | PDF ↗ |
| K132011 | APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET | Aea Srl | 2014-03-21 | Abbreviated | PDF ↗ |
| K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE | U&U Medical Technology Co, Ltd. | 2014-02-27 | Traditional | PDF ↗ |
| K132321 | JMS SYRINGE | JMS North America Corporation | 2014-02-20 | Traditional | PDF ↗ |
| K133021 | MIXING SYRINGE SYSTEM | Zimmer Knee Creations, Inc. | 2014-01-13 | Traditional | PDF ↗ |
| K132120 | WTF SECURA SYRINGE AND NEEDLE | Beijing Wantefu Medical Apparatus Co., Ltd. | 2013-12-12 | Traditional | PDF ↗ |
| K130230 | STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES | Wuxi Yushou Medical Applicances Co., Ltd. | 2013-11-20 | Traditional | PDF ↗ |
| K131661 | INFUSION SYRINGE SET | Innovative Medical Manufacturing Co. | 2013-11-05 | Traditional | PDF ↗ |
| K131963 | TAUTONA INJECTOR DEVICE | Tautona Group, LLC | 2013-10-22 | Traditional | PDF ↗ |
| K124037 | JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE | Jung Rim Medical Industrial Co., Ltd. | 2013-09-12 | Traditional | PDF ↗ |
| K131641 | MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) | Nipro Medical Corporation | 2013-08-28 | Traditional | PDF ↗ |
| K123766 | NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN | Novo Nordisk, Inc. | 2013-08-15 | Traditional | PDF ↗ |
| K130900 | EVICEL APPLICATION DEVICE | Ethicon Inc (On Behalf of Omrix Biopharaceuticals | 2013-08-13 | Traditional | PDF ↗ |
| K123710 | UNITOX BOTOX SYRINGE | Bio-Med USA, Inc. | 2013-05-09 | Traditional | PDF ↗ |
| K122416 | ARTIGLASS L. O.R. GLASS SYRINGE | Artiglass Srl | 2013-05-03 | Traditional | PDF ↗ |
| K123588 | INTRADERMAL ADAPTER | West Pharmaceutical Services, Inc. | 2013-02-19 | Traditional | PDF ↗ |
| K130049 | MONOJECT 12ML SYRINGE | Nipro Medical Corporation | 2013-02-14 | Special | PDF ↗ |
| K122787 | COMFORT EZ | Simple Diagnostics, Inc. | 2012-12-06 | Traditional | PDF ↗ |
| K122122 | REGEN SPRAY APPLICATOR, | Regen Lab SA | 2012-11-09 | Traditional | PDF ↗ |
| K122023 | MIXJECT WITH SPRAY HEAD | Medimop Medical Projects, Ltd. | 2012-10-04 | Traditional | PDF ↗ |
| K122373 | NEOMED ORAL/ENTERAL SYRINGE | Neomed, Inc. | 2012-09-20 | Special | PDF ↗ |
| K121476 | INFILL GRAFT DELIVERY SYSTEM | Pinnacle Spine Group, LLC | 2012-08-29 | Special | PDF ↗ |
| K113673 | MYSAFETY SYRINGE | Medicalchain Internartional Corporation | 2012-08-03 | Traditional | PDF ↗ |
Product code FMF · Class II · General Hospital. Data: openFDA.