Injector, Fluid, Non-Electrically Powered

FDA product code KZE · 53 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5430
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-12-08 – 2012-07-19

KZE 2012-07-19

BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM

Applicant Bioject Medical Technologies, Inc.

K number K121270

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KZE 2011-07-27

PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI

Applicant Pharmajet, Inc.

K number K111517

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KZE 2011-03-02

PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM

Applicant Pharmajet, Inc.

K number K110456

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KZE 2009-12-24

LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

Applicant D'Antonio Consultants International, Inc. (Dci)

K number K090959

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KZE 2009-04-02

ZETAJET

Applicant Bioject, Inc.

K number K090003

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KZE 2009-02-26

PHARMAJET NEEDLE-FREE INJECTION SYSTEM

Applicant Pharmajet, Inc.

K number K081532

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KZE 2009-01-23

AIRGENT, MODEL AG7000010

Applicant Perfaction, Inc.

K number K082138

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KZE 2006-06-16

COOL.CLICK 2

Applicant Medical House Products Limited

K number K060819

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KZE 2005-08-17

BIOVALVE MINI-JECT NEEDLEFREE INJECTOR

Applicant Biovalve Technologies, Inc.

K number K051985

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KZE 2005-06-03

COOL.CLICK

Applicant Bioject, Inc.

K number K050734

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KZE 2004-11-08

GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000

Applicant Genesis Medical Technology, Inc.

K number K041239

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KZE 2004-06-24

HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500

Applicant Felton International, Inc.

K number K041280

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KZE 2004-04-16

BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001

Applicant Biovalve Technologies, Inc.

K number K032976

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KZE 2003-01-17

AVANT GUARDIAN 101

Applicant Avant Medical Corporation

K number K024018

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KZE 2002-09-25

INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM

Applicant Rosch AG Medizintechnic

K number K020786

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KZE 2002-09-05

INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000

Applicant Equidyne Systems, Inc.

K number K022502

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KZE 2002-07-23

INJEX 30 NEEDLE FREE INJECTION SYSTEM

Applicant Equidyne Systems, Inc.

K number K022148

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KZE 2001-12-07

BI-3M NEEDLE-FREE INJECTOR SYSTEM

Applicant Felton International, Inc.

K number K013256

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KZE 2001-06-01

JET SYRINGE MODEL-100500

Applicant Equidyne Systems, Inc.

K number K003741

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KZE 2001-03-08

SEROJET

Applicant Bioject, Inc.

K number K003908

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KZE 2001-03-06

INJEX 50 SYSTEM

Applicant Equidyne Systems, Inc.

K number K003864

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KZE 2000-06-22

CLICKER

Applicant Bioject, Inc.

K number K994384

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KZE 1999-04-23

MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM

Applicant Medi-Ject Corp.

K number K991294

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KZE 1998-03-04

J-TIP NEEDLESS INJECTOR

Applicant National Medical Products, Inc.

K number K980082

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KZE 1997-11-24

J-TIP INJECTOR

Applicant National Medical Products, Inc.

K number K973254

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KZE 1997-03-05

BIOJECTOR 2000 MODEL 1B02000

Applicant Bioject, Inc.

K number K960373

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KZE 1996-12-10

VITAJET

Applicant Vitajet Corp.

K number K962625

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KZE 1996-10-07

MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM

Applicant Medi-Ject Corp.

K number K962956

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KZE 1996-04-17

MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC

Applicant Medi-Ject Corp.

K number K960285

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KZE 1995-11-20

MEDIVAX

Applicant Vitajet Corp.

K number K945548

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KZE 1995-08-18

HYPEX(TM) JET INJECTOR

Applicant Equidyne Systems, Inc.

K number K945873

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KZE 1994-06-28

BIOJECT JET INJECTION SYSTEM

Applicant Bioject, Inc.

K number K920631

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KZE 1992-11-17

PRECI-JET 50

Applicant Hmi Industries, Inc.

K number K921797

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KZE 1992-09-30

OPHTHALMIC VISCOINJECTOR DRIVE

Applicant Synergetics, Inc.

K number K923326

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KZE 1991-09-16

MED-E-JET INJECTOR

Applicant Med-E-Jet D

K number K913018

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KZE 1991-03-15

INJECTOR, INSULIN

Applicant Sound 2000 Medical Systems, Inc.

K number K905062

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KZE 1990-05-07

VITAJET(INSULIN JET INJECTION DEVICE)

Applicant Vitajet Industriae Comercioltda.

K number K893215

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KZE 1989-01-09

J-TIP INJECTOR SYSTEM

Applicant California Medical Innovations, Inc.

K number K884293

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KZE 1988-10-31

DERATA MEDI-JECTOR V

Applicant Derata Corp.

K number K883847

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KZE 1987-06-29

ROBINJECT

Applicant International Medical Products, Inc.

K number K864984

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KZE 1987-04-23

BIOJECTOR SYRINGE SYSTEM

Applicant Bioject, Inc.

K number K861687

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KZE 1987-02-19

DERATA MEDI-JECTOR IV

Applicant Derata Corp.

K number K864561

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KZE 1987-02-03

INJET-100, FLUID INJECTOR

Applicant Injet Medical Products, Inc.

K number K861582

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KZE 1986-01-01

JECT-AID

Applicant Autoject Systems, Inc.

K number K853031

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KZE 1985-12-10

MEDAJET XL - JET INJECTOR

Applicant Mada Medical Products, Inc.

K number K850754

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KZE 1985-07-05

DERATA MEDI-JECTOR PRO

Applicant Derata Corp.

K number K844244

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KZE 1985-07-01

VACUUM COMPRESSION INJECTOR

Applicant Uci Corp.

K number K851809

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KZE 1985-06-06

PRECI-JET 50

Applicant Ulster Scientific, Inc.

K number K851181

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KZE 1985-05-23

NEW VITAJET

Applicant Andrew V. Stadler

K number K851029

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KZE 1984-11-28

DERATA MEDI-JECTOR III

Applicant Derata Corp.

K number K844111

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KZE 1984-11-02

VITAJET JET INSULIN INJECTION DEVICE

Applicant Vitajet Industriae Comercioltda.

K number K843784

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KZE 1984-03-06

MEDI-JECTOR II

Applicant Derata Corp.

K number K834044

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KZE 1977-12-08

MEDI-JECTOR

Applicant Derata Corp.

K number K772129

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