FDA 510(k) Applications for Medical Device Product Code "KZE"
(Injector, Fluid, Non-Electrically Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K024018 AVANT MEDICAL CORPORATION AVANT GUARDIAN 101 01/17/2003
K121270 BIOJECT MEDICAL TECHNOLOGIES INC. BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM 07/19/2012
K960373 BIOJECT, INC. BIOJECTOR 2000 MODEL 1B02000 03/05/1997
K994384 BIOJECT, INC. CLICKER 06/22/2000
K050734 BIOJECT, INC. COOL.CLICK 06/03/2005
K003908 BIOJECT, INC. SEROJET 03/08/2001
K090003 BIOJECT, INC. ZETAJET 04/02/2009
K051985 BIOVALVE TECHNOLOGIES, INC. BIOVALVE MINI-JECT NEEDLEFREE INJECTOR 08/17/2005
K032976 BIOVALVE TECHNOLOGIES, INC. BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 04/16/2004
K090959 D'ANTONIO CONSULTANTS INTERNATIONAL, INC. (DCI) LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA 12/24/2009
K022148 EQUIDYNE SYSTEMS, INC. INJEX 30 NEEDLE FREE INJECTION SYSTEM 07/23/2002
K022502 EQUIDYNE SYSTEMS, INC. INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 09/05/2002
K003864 EQUIDYNE SYSTEMS, INC. INJEX 50 SYSTEM 03/06/2001
K003741 EQUIDYNE SYSTEMS, INC. JET SYRINGE MODEL-100500 06/01/2001
K013256 FELTON INTERNATIONAL, INC. BI-3M NEEDLE-FREE INJECTOR SYSTEM 12/07/2001
K041280 FELTON INTERNATIONAL, INC. HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 06/24/2004
K041239 GENESIS MEDICAL TECHNOLOGY, INC. GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 11/08/2004
K960285 MEDI-JECT CORP. MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC 04/17/1996
K962956 MEDI-JECT CORP. MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM 10/07/1996
K991294 MEDI-JECT CORP. MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM 04/23/1999
K060819 MEDICAL HOUSE PRODUCTS LIMITED COOL.CLICK 2 06/16/2006
K973254 NATIONAL MEDICAL PRODUCTS, INC. J-TIP INJECTOR 11/24/1997
K980082 NATIONAL MEDICAL PRODUCTS, INC. J-TIP NEEDLESS INJECTOR 03/04/1998
K082138 PERFACTION, INC. AIRGENT, MODEL AG7000010 01/23/2009
K110456 PHARMAJET, INC. PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM 03/02/2011
K081532 PHARMAJET, INC. PHARMAJET NEEDLE-FREE INJECTION SYSTEM 02/26/2009
K111517 PHARMAJET, INC. PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI 07/27/2011
K020786 ROSCH AG MEDIZINTECHNIC INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM 09/25/2002
K962625 VITAJET CORP. VITAJET 12/10/1996


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