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 2004-02-13

VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT

Applicant Vascular Solutions, Inc.

K number K033721

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FMF 2003-12-30

ULTICARE DISPOSABLE SYRINGE 3 ML/CC

Applicant Ultimed, Inc.

K number K033794

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FMF 2003-12-12

KACEY INSULIN SYRINGE

Applicant Kacey, Inc.

K number K033166

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FMF 2003-10-31

NIPRO DISPOSABLE SYRINGES

Applicant Nipro Medical Corp.

K number K030683

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FMF 2003-07-25

AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE

Applicant American Syringe Company

K number K031394

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FMF 2003-06-03

SHANCHUAN SYRINGE

Applicant Shangdong Zibo Shanchuan Medical Instruments Co.

K number K021993

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FMF 2003-04-16

IMBIBE II SYRINGE

Applicant Orthovita, Inc.

K number K030208

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FMF 2003-03-11

IMBIBE BONE MARROW ASPIRATION SYRINGE

Applicant Orthovita, Inc.

K number K023074

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FMF 2003-02-21

MERIT MEDICAL 1-ML SYRINGE

Applicant Merit Medical Systems, Inc.

K number K024052

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FMF 2003-02-07

BD INTEGRA SYRINGE

Applicant Bd

K number K023752

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FMF 2003-01-09

BD INSULIN SYRINGE

Applicant Becton, Dickinson & CO

K number K024112

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FMF 2002-12-18

TERUMO SYRINGE WITH/WITHOUT NEEDLE

Applicant Terumo Medical Corp.

K number K023271

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FMF 2002-12-03

STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE

Applicant Atlantic Products, Inc.

K number K023108

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FMF 2002-11-07

PISTON SYRINGE & HYPODERMIC NEEDLE

Applicant International Medsurg Connection

K number K022159

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FMF 2002-10-08

GETTIG DISPOSABLE SYRINGES

Applicant Gettig Pharmaceutical Instrument Co.

K number K022495

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FMF 2002-10-02

BONE GRAFT SYRINGE, MODEL 8600-00X0

Applicant Wrightmedicaltechnologyinc

K number K023088

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FMF 2002-08-02

MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM

Applicant Depuyacromed

K number K022246

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FMF 2002-07-03

LIGHT SABER SPINAL NEEDLE

Applicant Minrad, Inc.

K number K021084

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FMF 2002-07-01

PCCS GRAFT DELIVERY SYSTEM

Applicant Biomet, Inc.

K number K021071

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FMF 2002-06-26

GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX

Applicant Nipro Diabetes Systems, Inc.

K number K014114

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FMF 2002-06-24

DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML

Applicant Baxter Healthcare Corp

K number K020666

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FMF 2002-06-07

DUPLOREACH

Applicant Baxter Healthcare Corp

K number K014088

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FMF 2002-04-26

SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16

Applicant Hosuk Co., Ltd.

K number K021197

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FMF 2002-04-05

SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2

Applicant Harvest Technologies, Corp.

K number K020252

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FMF 2002-04-03

MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP

Applicant Medtronic Perfusion Systems

K number K020147

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FMF 2002-02-13

HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE

Applicant Portex, Inc.

K number K014073

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FMF 2001-10-29

MICROMEDICS FIBRIJET AEROSOL APPLICATOR

Applicant Micromedics, Inc.

K number K012868

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FMF 2001-09-19

ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE

Applicant Orthovita, Inc.

K number K011087

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FMF 2001-08-10

REUSABLE GLASS SYRINGES

Applicant Lockett Medical Corp.

K number K011176

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FMF 2001-08-02

EZ SYRINGE

Applicant Owen Mumford, Ltd.

K number K011951

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FMF 2001-06-29

THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM

Applicant Spintech, Inc.

K number K010692

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FMF 2001-04-30

APPLICATOR TIP/DUAL SPRAYER KIT

Applicant Interpore Cross Intl.

K number K010708

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FMF 2001-04-19

BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)

Applicant Becton, Dickinson and Co.

K number K010890

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FMF 2001-03-14

INNOVO

Applicant Novo Nordisk A/S

K number K010359

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FMF 2001-02-12

SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE

Applicant Terumo Medical Corp.

K number K003571

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FMF 2001-01-11

PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES

Applicant Pentaferte, S.R.L.

K number K002381

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FMF 2001-01-08

STERILE PISTON SYRINGE

Applicant Abbott Laboratories

K number K002717

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FMF 2000-12-29

INJECTRITE-C15 AND INJECTRITE-C30

Applicant Sterling Medivations, Inc.

K number K002127

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FMF 2000-12-12

GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES

Applicant Malgam Ent., Inc.

K number K002569

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FMF 2000-11-07

DUPLOGRIP

Applicant Baxter Healthcare Corp

K number K003193

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FMF 2000-10-18

SUREONE INSULIN SYRINGE

Applicant Hosuk Co., Ltd.

K number K002921

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FMF 2000-08-29

AVID-NIT LOSS OF RESISTANCE SYRINGE

Applicant Avid Medical, Inc.

K number K001731

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FMF 2000-07-05

TISSOMAT AND SPRAY SET

Applicant Baxter Healthcare Corp

K number K981089

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FMF 2000-06-09

TERUMO U-100 INSULIN SYRING

Applicant Terumo Medical Corp.

K number K001474

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FMF 2000-06-08

UNIVEC TWO PIECE SYRINGE

Applicant Univec, Inc.

K number K000747

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FMF 2000-06-06

THE WAND

Applicant Spintech, Inc.

K number K992404

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FMF 2000-06-01

HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2

Applicant Harvest Technologies, LLC

K number K000456

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FMF 2000-05-03

MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER

Applicant Biosurgical Corp.

K number K000438

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FMF 2000-04-25

HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01

Applicant Haemacure Corp.

K number K994023

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FMF 2000-03-24

ULTICARE DISPOSABLE SYRINGE

Applicant Ultimed, Inc.

K number K994230

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FMF 2000-02-25

PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE

Applicant Shinchang Medical Co., Ltd.

K number K993017

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FMF 2000-02-14

VEIN ENTRY INDICATOR DEVICE (VEID)

Applicant Vascular Technologies , Ltd.

K number K993995

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FMF 2000-02-11

NIPRO INSULIN SYRINGE

Applicant Nipro Medical Corp.

K number K000144

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FMF 2000-01-31

SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1

Applicant Biosurgical Corp.

K number K000048

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FMF 2000-01-05

VACLOK SYRINGE

Applicant Merit Medical Systems, Inc.

K number K994253

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FMF 1999-11-22

DISETRONIC PEN P100

Applicant Disetronic Medical Systems

K number K993666

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FMF 1999-10-08

SEALOUETTE FIBRIN SEALANT APPLICATOR

Applicant Biosurgical Corp.

K number K992351

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FMF 1999-09-09

TERUMO U-100 INSULIN SYRINGE

Applicant Terumo Medical Corp.

K number K992802

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FMF 1999-07-08

MTI 1 ML SYRINGE

Applicant Micro Therapeutics, Inc.

K number K991225

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FMF 1999-06-24

TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

Applicant Te ME NA S.A.R.L.

K number K990020

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FMF 1999-06-14

MONOJECT INSULIN SYRINGE

Applicant The Kendal Co.

K number K991758

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FMF 1999-05-21

EASYSAFE RETRACTING NEEDLE SYRINGE

Applicant Saf-T-Med, Inc.

K number K991039

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FMF 1999-03-04

ALLISON MEDICAL INSULIN SYRINGE (AMIS)

Applicant Allison Medical, Inc.

K number K984017

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FMF 1999-02-09

LITE-TOUCH SYRINGE

Applicant Medicore, Inc.

K number K983430

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FMF 1999-01-08

UNIFINE

Applicant Owen Mumford USA, Inc.

K number K983994

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FMF 1998-12-21

OWEN MUMFORD 3ML AUTOPEN

Applicant Owen Mumford USA, Inc.

K number K983974

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FMF 1998-10-19

DISETRONIC PEN

Applicant Disetronic Medical Systems

K number K982966

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FMF 1998-10-16

PENETREASE

Applicant P.T. Panca Pusaka Deli

K number K980078

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FMF 1998-09-25

HUMAPEN AND HUMAPEN ERGO

Applicant Eli Lilly and Co.

K number K982842

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FMF 1998-08-07

LIGHT SABER ASPIRATION NEEDLE

Applicant Minrad, Inc.

K number K982018

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FMF 1998-07-15

STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K972728

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FMF 1998-06-25

MINRAD DRTS LIGHT SABER SYRINGE

Applicant Minrad, Inc.

K number K981140

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FMF 1998-06-25

BECTON DICKINSON SYRINGES

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K980580

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FMF 1998-06-12

B-D PEN ULTRA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K981797

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FMF 1998-06-11

BECTON DICKINSON SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K980987

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FMF 1998-05-01

GLASS VAN GLASS SYRINGES

Applicant Myco Medical Supplies, Inc.

K number K963364

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FMF 1998-04-02

TERUMO ALLERGY SYRINGE

Applicant Terumo Corp.

K number K980796

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FMF 1998-04-02

B-D E ML PEN

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K980755

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FMF 1998-04-02

TERUMO DISPOSABLE HYPODERMC SYRINGE

Applicant Terumo Medical Corp.

K number K980181

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FMF 1998-02-26

ULTRASAFE MODEL T200 INJECTOR

Applicant Safety Syringes, Inc.

K number K972900

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FMF 1998-02-26

ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD

Applicant Safety Syringes, Inc.

K number K972877

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FMF 1997-12-22

DAXOR MAX100 SYRINGE (MAX100)

Applicant Daxor Corporation

K number K970419

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FMF 1997-12-08

DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)

Applicant Immuno-U.S., Inc.

K number K973510

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FMF 1997-10-30

ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300

Applicant Safety Syringes, Inc.

K number K972878

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FMF 1997-09-08

BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE

Applicant Biosurgical Corp.

K number K964597

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FMF 1997-07-25

RAMY PISTON SYRINGE

Applicant Alshifa Medical Syringes Mfg. Co., Ltd.

K number K971664

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FMF 1997-07-24

RAMY INTEGRATED NEEDLE SYRINGE

Applicant Alshifa Medical Syringes Mfg. Co., Ltd.

K number K972452

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FMF 1997-07-24

CORELIFE

Applicant Core Healthcare , Ltd.

K number K964230

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FMF 1997-03-04

BRANNON ARTERIO-VENOUS PORTSYRINGE

Applicant Vascular Logics, Inc.

K number K965030

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FMF 1997-02-10

OMNICAN SYRINGE

Applicant B. Braun Medical AG

K number K962084

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FMF 1996-12-24

COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE

Applicant Travenol Laboratories (Israel) , Ltd.

K number K964060

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FMF 1996-12-19

IRT LOCKING SYRINGE

Applicant Interventional Research Technologies

K number K945410

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FMF 1996-11-22

DRESSING CHANGE TRAYS

Applicant Busse Hospital Disposables, Inc.

K number K963260

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FMF 1996-10-08

GLASS SYRINGE

Applicant Ispg, Inc.

K number K962042

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FMF 1996-09-12

GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10

Applicant Global Medical Prods, Inc.

K number K962329

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FMF 1996-09-06

SHIFA STERILE DISPOSABLE SYRINGES

Applicant International Regulatory Consultants

K number K962614

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FMF 1996-07-25

PISTON SYRINGE

Applicant Medical Surgical Intl.

K number K955606

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FMF 1996-07-08

CONTROL SYRINGE

Applicant Louisville Laboratories, Inc.

K number K960882

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FMF 1996-05-24

BRANNON PORTSYRINGE

Applicant James K. Brannon

K number K960049

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FMF 1996-05-24

BRANNON PEDI PORTSYRINGE

Applicant James K. Brannon

K number K960047

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