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 |