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 1996-05-21

TERUMO RETRACTABLE NEEDLE (RN) SYRINGE

Applicant Terumo Medical Corp.

K number K953940

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FMF 1996-05-06

THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS

Applicant Thermogenesis Corp.

K number K955282

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FMF 1996-04-12

GENERAL PROCEDURE KIT

Applicant Physician Industries, Inc.

K number K960248

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FMF 1996-03-20

S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)

Applicant Habley Medical Technology Corp.

K number K955164

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FMF 1996-02-16

UNIQUE NEEDLE WITH FIRM GRIP SHIELD

Applicant Unique Management Ent., Inc.

K number K950666

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FMF 1995-12-06

UNIQUE NEEDLE

Applicant Unique Management Ent., Inc.

K number K950245

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FMF 1995-12-01

SYRINGE MAGNIFIER

Applicant Innovative Premiums, Inc.

K number K953626

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FMF 1995-11-29

DISPOSABLE SYRINGE

Applicant Surgiplast , Ltd.

K number K950969

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FMF 1995-11-21

BECTON DICKINSON SYRINGSE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K954064

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FMF 1995-11-13

GENOTROPIN MIXER

Applicant Pharmacia, Inc.

K number K954337

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FMF 1995-10-24

B-D PEN ULTRA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K951919

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FMF 1995-10-19

EASI-JECTOR CONTROL SYSTEM

Applicant North, Inc.

K number K954189

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FMF 1995-10-19

PISTON SYRINGE

Applicant Pharmacia, Inc.

K number K951025

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FMF 1995-10-04

PORT-A-CATH ACCESS KIT

Applicant Medi-Flex Hospital Products, Inc.

K number K952201

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FMF 1995-10-03

ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE

Applicant Alpha Medica

K number K952553

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FMF 1995-09-29

REUSABLE ALL - GLASS SYRINGES

Applicant Top Syringe Mfg. Co.

K number K944542

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FMF 1995-09-22

COLLAPSIBLE HYPODERMIC SYRINGE

Applicant Roman Vladimirsky

K number K951980

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FMF 1995-09-15

PTFE SYRINGE FILTER

Applicant B.Braun Medical, Inc.

K number K952918

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FMF 1995-08-25

STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS

Applicant Stryker Corp.

K number K950824

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FMF 1995-07-20

SURGICAL TECHNOLOGIES, INC. SYRINGE

Applicant Surgical Technologies, Inc.

K number K951918

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FMF 1995-07-14

VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE

Applicant Vlv Associates, Inc.

K number K945592

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FMF 1995-06-21

PISTON SYRINGE

Applicant Baxa Corp.

K number K951871

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FMF 1995-06-06

UNIVEC NONREUSABLE LOCKING SYRINGE

Applicant Univec, Inc.

K number K951619

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FMF 1995-05-19

STERILE EMPTY PCA SYRINGE

Applicant Intl. Medication Systems, Ltd.

K number K945797

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FMF 1995-04-26

NOVOPEN 1.5

Applicant Novo Nordisk Pharmaceuticals, Inc.

K number K942159

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FMF 1995-04-13

HYPODERMIC SYRINGE PISTON

Applicant Ispg, Inc.

K number K950133

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FMF 1995-03-17

DRUG DISPENSING SPIKE

Applicant Gelman Sciences, Inc.

K number K946190

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FMF 1995-03-01

MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES

Applicant Sherwood Medical Co.

K number K945715

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FMF 1995-02-10

DISPOSABLE 1CC SYRINGE WITH LUER LOCK

Applicant Interventional Therapeutics Corp.

K number K945588

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FMF 1995-01-31

SAFE-1(TM) SYRINGE

Applicant Safety 1st Medical, Inc.

K number K940635

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FMF 1995-01-27

SAFE VENT SYSTEM

Applicant Incutech, Inc.

K number K942394

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FMF 1995-01-26

DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES

Applicant Myco Medical Supplies, Inc.

K number K945225

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FMF 1994-12-20

CG DISPOSABLE SYRINGE

Applicant Fortunique Medical Products

K number K944920

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FMF 1994-12-12

DISPOSABLE DISC FILTER

Applicant Medi-Dose, Inc.

K number K936015

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FMF 1994-12-07

NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES

Applicant Nissho Corp.

K number K944355

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FMF 1994-09-06

SYRINGE FILTER DEVICES

Applicant Gelman Sciences, Inc.

K number K941589

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FMF 1994-08-10

DRUG RECONSTITUTION FILTER DEVICE

Applicant Gelman Sciences, Inc.

K number K941020

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FMF 1994-08-05

IRRIGATION TRAY WITH PISTON SYRINGE

Applicant Trinity Laboratories, Inc.

K number K942221

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FMF 1994-07-21

SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K942615

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FMF 1994-06-17

MEDSAVER SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K941095

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FMF 1994-06-10

CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM

Applicant Contour Fabricators of Florida, Inc.

K number K935092

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FMF 1994-05-27

UNKNOWN

Applicant Gelman Sciences, Inc.

K number K941032

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FMF 1994-05-26

BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K941657

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FMF 1994-05-26

1ML LUER-LOK SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K941562

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FMF 1994-05-23

ADVANTAGE SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K941545

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FMF 1994-04-22

CUSTOM SYRIGENE KITS

Applicant Syrigene Medical Technologies, Inc.

K number K925822

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FMF 1994-03-01

RIVER VIAL ADAPTER

Applicant River Medical, Inc.

K number K933335

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FMF 1994-02-22

CAREJECT DISPOSABLE SYRINGE AND NEEDLE

Applicant Carewell Mediproducts, Ltd.

K number K931472

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FMF 1994-02-10

ONE TIME VIAL ACCESS SPIKE

Applicant Icu Medical, Inc.

K number K934561

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FMF 1994-02-09

MEDIJECT DISPOSABLE SYRINGES

Applicant P.T. Igar Jaya

K number K920039

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FMF 1994-01-21

ALLISON MEDICAL SYRINGE

Applicant Allison Medical, Inc.

K number K932001

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FMF 1993-12-13

BASIC SKIN PREP TRAY

Applicant Mcbar Industries

K number K932361

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FMF 1993-09-28

EDGE SYRINGES AND NEEDLES

Applicant Trico Intl., Inc.

K number K923321

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FMF 1993-09-16

SPRING LOADED SYRINGE

Applicant Acacia, Inc.

K number K931095

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FMF 1993-08-24

I.D.A. SYRINGES

Applicant Pt Hasoon Chandra

K number K931632

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FMF 1993-08-06

AMERICAN POWER CONVERSIONS, BACK-UPS 600

Applicant Bio Clinic Co.

K number K930791

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FMF 1993-07-29

MONOJECT(R) 6 CC SAFETY SYRINGE

Applicant Sherwood Medical Co.

K number K924511

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FMF 1993-07-13

FIBRACOL COLLAGEN-ALGINATE DRESSING

Applicant Johnson & Johnson Medical, Inc.

K number K925548

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FMF 1993-07-13

GENESIS SPRAY TIP ATOMIZER

Applicant Mai

K number K923183

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FMF 1993-07-12

ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY

Applicant Sherwood Medical Co.

K number K930847

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FMF 1993-06-29

NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE

Applicant Novo Nordisk Pharmaceuticals, Inc.

K number K921908

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FMF 1993-05-17

BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K930321

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FMF 1993-04-07

BECTON DICKINSON ARTERIAL BLOOD GAS KITS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K930342

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FMF 1993-02-23

ACCESSORY TO PISTON SYRINGE

Applicant Martech Medical Products, Inc.

K number K926007

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FMF 1993-01-27

RACK AND SYRINGES

Applicant Normeca Corp.

K number K915780

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FMF 1992-12-17

BECTON DICKINSON SAFETY-LOK SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K924072

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FMF 1992-11-25

MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES

Applicant Sherwood Medical Co.

K number K922522

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FMF 1992-11-06

PRIMARY SURGICAL DRESSING TRAY

Applicant Transidyne General Corp.

K number K922041

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FMF 1992-10-23

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

Applicant Advanced Surgical, Inc.

K number K922190

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FMF 1992-09-30

VISITEC ASPIRATING SYRINGE

Applicant Visitec Co.

K number K923645

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FMF 1992-09-21

ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD

Applicant ETHICON, Inc.

K number K921833

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FMF 1992-09-11

SPLATTER SHIELD

Applicant Chathamborough Research Group, Inc.

K number K915676

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FMF 1992-07-13

IRRIGATING SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K912437

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FMF 1992-04-29

B-D INTERLINK SYRINGE CANNULA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K920422

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FMF 1992-04-20

BECTON DICKINSON SAFETY-LOK SYRINGE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K920321

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FMF 1992-04-15

CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT

Applicant Medi-Flex Hospital Products, Inc.

K number K920398

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FMF 1992-04-09

NEO-THOR THORACOSTOMY KIT

Applicant Intl. Medical Devices , Ltd.

K number K913541

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FMF 1992-04-09

PEDIA-THOR THORACOSTOMY KIT

Applicant Intl. Medical Devices , Ltd.

K number K913540

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FMF 1992-01-02

IDEAS' PORT

Applicant Ideal Medical, Inc.

K number K913602

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FMF 1992-01-02

TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT

Applicant Gerard Medical Enterprises, Inc.

K number K913114

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FMF 1991-12-30

RAPI-JECT(R) SYRINGE

Applicant David Bull Laboratories, USA, Inc.

K number K911440

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FMF 1991-12-17

PALCO LABS LOADMATIC

Applicant Palco Laboratories, Inc.

K number K913694

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FMF 1991-10-31

DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH

Applicant Davol, Inc.

K number K913235

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FMF 1991-10-11

B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K912330

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FMF 1991-10-08

MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE

Applicant Gerard Medical Enterprises, Inc.

K number K912111

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FMF 1991-10-08

CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM

Applicant Burron Medical, Inc.

K number K902401

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FMF 1991-05-07

DISPOSABLE RETRACTABLE NEEDLE SYRINGE

Applicant Safe Tech Medical Products, Inc.

K number K910731

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FMF 1991-04-16

SAFETYSNAP SAFETY SYRINGE

Applicant U.S. Medical Instruments, Inc.

K number K910520

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FMF 1991-03-22

DAVID SIMMONDS ANESTHESIA EXTENSION TUBES

Applicant Sparta Surgical Corp.

K number K905384

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FMF 1991-03-15

STERAID DISPOSABLE SYRINGE

Applicant Disposable Medi-Aids , Ltd.

K number K904620

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FMF 1990-12-21

YUEFA DISPOSABLE SYRINGE

Applicant Blue & Red Corp.

K number K902178

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FMF 1990-11-29

JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR

Applicant Johnson & Johnson Medical, Inc.

K number K902157

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FMF 1990-10-17

SAFE-T-STIK

Applicant Xikon Technology

K number K904382

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FMF 1990-09-26

INSULIN SYRINGE GUIDE

Applicant Bay State Anesthesia, Inc.

K number K903426

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FMF 1990-09-07

SHARGHP INSULIN SYRINGES

Applicant Shargh Pharmaceutical Co., Inc.

K number K895980

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FMF 1990-09-07

SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE

Applicant Shargh Pharmaceutical Co., Inc.

K number K895810

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FMF 1990-07-02

NEEDLEPOINT GUARD

Applicant Needlepoint Guard, Inc.

K number K901546

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FMF 1990-06-26

DISPOSABLE CORONARY CONTROL SYRINGE

Applicant Advance Medical Designs, Inc.

K number K902346

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FMF 1990-06-14

RETRAX SAFETY SYRINGE

Applicant Retrax, Inc.

K number K901508

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FMF 1990-06-06

HYPODERMIC SYRINGE LUER LOK

Applicant Ware-Medics Glass Works, Inc.

K number K901203

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