Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Syringe, Piston

FDA product code FMF · 731 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5860
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-23 – 2026-08-26

FMF 2021-01-07

Instylla Delivery Kit

Applicant Instylla, Inc.

K number K202544

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FMF 2021-01-05

Insulin Syringe

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K number K193273

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FMF 2020-12-17

S dispensing line

Applicant Aea Srl

K number K192770

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FMF 2020-12-14

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

Applicant Set Medikal Sanayi VE Ticaret Anonim Sirketi

K number K201284

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FMF 2020-10-16

ARTHROTAP

Applicant Accuro Technologies, Inc.

K number K201816

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FMF 2020-09-03

3D GraftRasp System

Applicant Surgentec

K number K201900

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FMF 2020-07-17

Syringe with safety needle, Safety needle

Applicant Jiangsu Caina Medical Co.,Ltd

K number K193526

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FMF 2020-07-15

BD SoloShot Mini Syringe/ BD Auto Disable Syringe

Applicant Becton, Dickinson and Company

K number K201234

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FMF 2020-07-14

Orbit Subretinal Delivery System

Applicant Orbit Biomedical

K number K200325

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FMF 2020-07-13

Allograft MIS Delivery System

Applicant Lifenet Health

K number K201338

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FMF 2020-05-29

Aspire Mechanical Aspirator G

Applicant Control Medical Technology

K number K200629

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FMF 2020-05-18

3D GraftRasp System

Applicant Surgentec

K number K200431

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FMF 2020-05-01

O-Genesis Graft Delivery System

Applicant Orthofix, Inc.

K number K200606

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FMF 2020-03-05

Omnifix Low Dead Space Luer Lock Syringe

Applicant B.Braun Medical, Inc.

K number K193101

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FMF 2020-02-18

Mixing and Delivery System

Applicant Bone Solutions, Inc.

K number K192674

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FMF 2020-01-31

Tamper Evident Cap

Applicant International Medical Industries, Inc.

K number K193192

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FMF 2020-01-06

TK Sterile Piston Syringe without Needle

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K number K191642

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FMF 2019-10-21

BD Insulin Syringe

Applicant Becton, Dickinson and Company

K number K190054

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FMF 2019-10-10

Instylla Delivery Kit

Applicant Instylla, Inc.

K number K191659

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FMF 2019-10-09

Nipro Syringe

Applicant Nipro Medical Corporation

K number K191359

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FMF 2019-09-27

EpiFaith Syringe

Applicant Flat Medical Co., Ltd.

K number K192421

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FMF 2019-09-12

Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use

Applicant Shanghai Kohope Medical Devices Co., Ltd.

K number K190002

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FMF 2019-09-06

Sure-Fine Insulin Syringes

Applicant Shina Med Corporation

K number K191531

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FMF 2019-09-03

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

Applicant Top Corporation

K number K182765

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FMF 2019-07-28

Bonus Therapeutics Mixing and Delivery System

Applicant Bonus Therapeutics , Ltd.

K number K190996

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FMF 2019-07-18

Immucise

Applicant Terumo Corporation

K number K190427

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FMF 2019-04-05

EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

Applicant Flat Medical Co., Ltd.

K number K182268

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FMF 2019-03-14

BD Plastipak Syringe

Applicant Becton, Dickinson and Company

K number K182589

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FMF 2018-12-17

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)

Applicant Novo Nordisk, Inc.

K number K182387

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FMF 2018-11-20

Orbit Subretinal Delivery System

Applicant Orbit Biomedical, Inc.

K number K182274

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FMF 2018-11-06

Merit Syringe

Applicant Merit Medical Systems, Inc.

K number K182279

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FMF 2018-11-06

Merit Syringe

Applicant Merit Medical Systems, Inc.

K number K182216

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FMF 2018-10-23

BD Single Use, Hypodermic Syringe

Applicant Becton, Dickinson and Company

K number K172670

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FMF 2018-05-10

Graftgun Universal Graft Delivery System

Applicant SurGenTec, LLC

K number K180937

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FMF 2018-03-30

Nipro Syringe

Applicant Nipro Medical Corporation

K number K173029

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FMF 2018-01-31

Merit Syringe

Applicant Merit Medical Systems, Inc.

K number K173601

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FMF 2017-11-30

Graft Delivery, DePuy Synthes

Applicant Micromedics, Inc. (D/B/A Nordson Medical)

K number K173385

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FMF 2017-11-09

DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories

Applicant Intervene Group, Ltd.

K number K170900

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FMF 2017-11-08

MHC Standard and NRFit Tip Syringes

Applicant Mazza Healthcare, LLC

K number K171131

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FMF 2017-09-08

Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml

Applicant Conceptomed AS

K number K171805

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FMF 2017-08-07

Merit Syringe

Applicant Merit Medical Systems, Inc.

K number K171362

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FMF 2017-07-19

Graftgun Universal Graft Delivery System

Applicant SurGenTec, LLC

K number K170675

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FMF 2017-06-09

CompuFlo Epidural Computer Controlled Anesthesia System

Applicant Milestone Scientific, Inc.

K number K161883

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FMF 2017-04-12

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

Applicant Becton Dickinson & Company

K number K170386

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FMF 2017-03-27

Freedom Syringe

Applicant Procedure Products, Inc.

K number K161812

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FMF 2017-03-20

Sterile Single-use Syringe with Needle

Applicant Jiangxi Hongda Medical Equipment Group , Ltd.

K number K163161

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FMF 2017-02-24

Vesco Medical NRFit Tip Syringes

Applicant Vesco Medical, LLC

K number K170218

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FMF 2017-02-10

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

Applicant Terumo Europe N.V.

K number K161606

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FMF 2017-01-11

ConceptoMed Luer-Jack Slip 10ml

Applicant Conceptomed AS

K number K162057

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FMF 2016-12-29

Disposable Insulin Syringe

Applicant Berpu Medical Technology Co., Ltd.

K number K162180

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FMF 2016-12-19

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

Applicant Becton, Dickinson and Company

K number K162081

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FMF 2016-10-18

NovoPen Echo

Applicant Novo Nordisk, Inc.

K number K162602

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FMF 2016-09-16

Bone Solutions Mixing and Delivery System

Applicant Bone Solutions, Inc.

K number K161568

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FMF 2016-09-09

Sure-Fine Insulin Syringes

Applicant Shina Med Corporation

K number K152879

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FMF 2016-07-26

InPen

Applicant Companion Medical, Inc.

K number K160629

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FMF 2016-07-12

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

Applicant Sung Shim Medicare Co., Ltd.

K number K152803

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FMF 2016-07-08

LITe BIO Delivery System

Applicant Stryker Corporation

K number K160978

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FMF 2016-07-08

BD U-500 INSULIN SYRINGE

Applicant Becton, Dickinson and Company

K number K151870

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FMF 2016-06-17

Sol-M Insulin Syringe, Sol-M TB Syringe

Applicant Sol-Millennium Medical, Inc.

K number K153537

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FMF 2016-06-03

HumaPen Savvio

Applicant Eli Lilly and Company, Inc.

K number K160668

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FMF 2016-05-17

SiO2 Coated syringe 3 ml

Applicant Sio2 Medical Products

K number K153553

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FMF 2013-12-12

WTF SECURA SYRINGE AND NEEDLE

Applicant Beijing Wantefu Medical Apparatus Co., Ltd.

K number K132120

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FMF 2013-11-20

STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES

Applicant Wuxi Yushou Medical Applicances Co., Ltd.

K number K130230

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FMF 2013-11-05

INFUSION SYRINGE SET

Applicant Innovative Medical Manufacturing Co.

K number K131661

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FMF 2013-10-22

TAUTONA INJECTOR DEVICE

Applicant Tautona Group, LLC

K number K131963

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FMF 2013-09-12

JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE

Applicant Jung Rim Medical Industrial Co., Ltd.

K number K124037

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FMF 2013-08-28

MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)

Applicant Nipro Medical Corporation

K number K131641

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FMF 2013-08-15

NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN

Applicant Novo Nordisk, Inc.

K number K123766

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FMF 2013-08-13

EVICEL APPLICATION DEVICE

Applicant Ethicon Inc (On Behalf of Omrix Biopharaceuticals

K number K130900

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FMF 2013-05-09

UNITOX BOTOX SYRINGE

Applicant Bio-Med USA, Inc.

K number K123710

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FMF 2013-05-03

ARTIGLASS L. O.R. GLASS SYRINGE

Applicant Artiglass Srl

K number K122416

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FMF 2013-02-19

INTRADERMAL ADAPTER

Applicant West Pharmaceutical Services, Inc.

K number K123588

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FMF 2013-02-14

MONOJECT 12ML SYRINGE

Applicant Nipro Medical Corporation

K number K130049

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FMF 2012-12-06

COMFORT EZ

Applicant Simple Diagnostics, Inc.

K number K122787

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FMF 2012-11-09

REGEN SPRAY APPLICATOR,

Applicant Regen Lab SA

K number K122122

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FMF 2012-10-04

MIXJECT WITH SPRAY HEAD

Applicant Medimop Medical Projects, Ltd.

K number K122023

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FMF 2012-09-20

NEOMED ORAL/ENTERAL SYRINGE

Applicant Neomed, Inc.

K number K122373

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FMF 2012-08-29

INFILL GRAFT DELIVERY SYSTEM

Applicant Pinnacle Spine Group, LLC

K number K121476

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FMF 2012-08-03

MYSAFETY SYRINGE

Applicant Medicalchain Internartional Corporation

K number K113673

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FMF 2012-05-30

BD EMERALD SAF-T SINGLE USE, HYPODERMIC

Applicant Becton, Dickinson and Company

K number K121283

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FMF 2012-05-16

ARTHREX MIXING AND DELIVERY SYSTEM

Applicant Arthrex, Inc.

K number K121124

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FMF 2012-03-01

SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

Applicant Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.

K number K111841

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FMF 2011-12-14

KDL SYRINGES AND NEEDLE

Applicant Shanghai Kindly Enterprise Dev. Group Co.,

K number K112057

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FMF 2011-11-28

BD EMERALD SINGLE USE, HYPODERMIC SYRINGE

Applicant Becton Dickinson

K number K113241

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FMF 2011-11-10

XTRACT SYRINGE KEY SYSTEM

Applicant Xtract Solutions

K number K112475

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FMF 2011-08-18

IMC INSULIN SYRINGE

Applicant International Medsurg Connection

K number K110882

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FMF 2011-08-11

INFILL GRAFT DELIVERY SYSTEM

Applicant Pinnacle Spine Group, LLC

K number K111632

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FMF 2011-07-29

JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)

Applicant Jiangsu Shenli Medical Production Factory

K number K103830

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FMF 2011-07-14

TIGER SYRINGES AND NEEDLES

Applicant Tiger Medical Products, Ltd.

K number K110697

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FMF 2011-06-24

MERIT MEDICAL 20 ML SYRINGE

Applicant Merit Medical Systems, Inc.

K number K111091

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FMF 2011-06-10

DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE

Applicant Dmc Medical, Ltd.

K number K103736

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FMF 2011-05-13

BD SINGLE USE, HYPODERMIC SYRINGE

Applicant Becton, Dickinson and Company

K number K110771

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FMF 2011-04-26

DISPOSABLE INSULIN SYRINGE

Applicant Wenzhou Wuzhou Import & Export Co., Ltd.

K number K110421

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FMF 2011-04-20

CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE

Applicant Rongshan LI

K number K110112

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FMF 2011-04-12

PROPEP DELIVERY DEVICE

Applicant Rhythmlink International, LLC

K number K103200

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FMF 2011-02-24

PATIENT SAFE LUER CAP

Applicant Retractable Technologies, Inc.

K number K101708

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FMF 2011-02-23

INDISCAL DIGITAL MANOMETER

Applicant Baylis Medical Co., Inc.

K number K102192

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FMF 2010-12-20

IMC PISTON SYRINGES

Applicant International Medsurg Connection

K number K102969

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FMF 2010-11-22

HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)

Applicant Henke-Sass, Wolf GmbH

K number K101547

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FMF 2010-09-02

EASY TOUCH

Applicant Mhc Medical Products

K number K102178

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