Panels › General Hospital › Product code KZE · Class 2
Injector, Fluid, Non-Electrically Powered
Regulation 880.5430
0510(k)s in 12 months (53 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in KZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioject, Inc. | 7 | 0 |
| Derata Corp. | 6 | 0 |
| Equidyne Systems, Inc. | 5 | 0 |
| Medi-Ject Corp. | 3 | 0 |
| Pharmajet, Inc. | 3 | 0 |
| Biovalve Technologies, Inc. | 2 | 0 |
| Felton International, Inc. | 2 | 0 |
| National Medical Products, Inc. | 2 | 0 |
| Vitajet Corp. | 2 | 0 |
| Vitajet Industriae Comercioltda. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 2012 | K121270 | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM Bioject Medical Technologies, Inc. | KZE |
| Jul 27, 2011 | K111517 | PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI Pharmajet, Inc. | KZE |
| Mar 2, 2011 | K110456 | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM Pharmajet, Inc. | KZE |
| Dec 24, 2009 | K090959 | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA D'Antonio Consultants International, Inc. (Dci) | KZE |
| Apr 2, 2009 | K090003 | ZETAJET Bioject, Inc. | KZE |
| Feb 26, 2009 | K081532 | PHARMAJET NEEDLE-FREE INJECTION SYSTEM Pharmajet, Inc. | KZE |
| Jan 23, 2009 | K082138 | AIRGENT, MODEL AG7000010 Perfaction, Inc. | KZE |
| Jun 16, 2006 | K060819 | COOL.CLICK 2 Medical House Products Limited, GB | KZE |
| Aug 17, 2005 | K051985 | BIOVALVE MINI-JECT NEEDLEFREE INJECTOR Biovalve Technologies, Inc. | KZE |
| Jun 3, 2005 | K050734 | COOL.CLICK Bioject, Inc. | KZE |
| Nov 8, 2004 | K041239 | GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 Genesis Medical Technology, Inc. | KZE |
| Jun 24, 2004 | K041280 | HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 Felton International, Inc. | KZE |
| Apr 16, 2004 | K032976 | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 Biovalve Technologies, Inc. | KZE |
| Jan 17, 2003 | K024018 | AVANT GUARDIAN 101 Avant Medical Corporation | KZE |
| Sep 25, 2002 | K020786 | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM Rosch AG Medizintechnic, DE | KZE |
| Sep 5, 2002 | K022502 | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 Equidyne Systems, Inc. | KZE |
| Jul 23, 2002 | K022148 | INJEX 30 NEEDLE FREE INJECTION SYSTEM Equidyne Systems, Inc. | KZE |
| Dec 7, 2001 | K013256 | BI-3M NEEDLE-FREE INJECTOR SYSTEM Felton International, Inc. | KZE |
| Jun 1, 2001 | K003741 | JET SYRINGE MODEL-100500 Equidyne Systems, Inc. | KZE |
| Mar 8, 2001 | K003908 | SEROJET Bioject, Inc. | KZE |
| Mar 6, 2001 | K003864 | INJEX 50 SYSTEM Equidyne Systems, Inc. | KZE |
| Jun 22, 2000 | K994384 | CLICKER Bioject, Inc. | KZE |
| Apr 23, 1999 | K991294 | MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM Medi-Ject Corp. | KZE |
| Mar 4, 1998 | K980082 | J-TIP NEEDLESS INJECTOR National Medical Products, Inc. | KZE |
| Nov 24, 1997 | K973254 | J-TIP INJECTOR National Medical Products, Inc. | KZE |
| Mar 5, 1997 | K960373 | BIOJECTOR 2000 MODEL 1B02000 Bioject, Inc. | KZE |
| Dec 10, 1996 | K962625 | VITAJET Vitajet Corp. | KZE |
| Oct 7, 1996 | K962956 | MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM Medi-Ject Corp. | KZE |
| Apr 17, 1996 | K960285 | MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC Medi-Ject Corp. | KZE |
| Nov 20, 1995 | K945548 | MEDIVAX Vitajet Corp. | KZE |
| Aug 18, 1995 | K945873 | HYPEX(TM) JET INJECTOR Equidyne Systems, Inc. | KZE |
| Jun 28, 1994 | K920631 | BIOJECT JET INJECTION SYSTEM Bioject, Inc. | KZE |
| Nov 17, 1992 | K921797 | PRECI-JET 50 Hmi Industries, Inc., CA | KZE |
| Sep 30, 1992 | K923326 | OPHTHALMIC VISCOINJECTOR DRIVE Synergetics, Inc. | KZE |
| Sep 16, 1991 | K913018 | MED-E-JET INJECTOR Med-E-Jet D | KZE |
| Mar 15, 1991 | K905062 | INJECTOR, INSULIN Sound 2000 Medical Systems, Inc. | KZE |
| May 7, 1990 | K893215 | VITAJET(INSULIN JET INJECTION DEVICE) Vitajet Industriae Comercioltda., BR | KZE |
| Jan 9, 1989 | K884293 | J-TIP INJECTOR SYSTEM California Medical Innovations, Inc. | KZE |
| Oct 31, 1988 | K883847 | DERATA MEDI-JECTOR V Derata Corp. | KZE |
| Jun 29, 1987 | K864984 | ROBINJECT International Medical Products, Inc. | KZE |
| Apr 23, 1987 | K861687 | BIOJECTOR SYRINGE SYSTEM Bioject, Inc. | KZE |
| Feb 19, 1987 | K864561 | DERATA MEDI-JECTOR IV Derata Corp. | KZE |
| Feb 3, 1987 | K861582 | INJET-100, FLUID INJECTOR Injet Medical Products, Inc. | KZE |
| Jan 1, 1986 | K853031 | JECT-AID Autoject Systems, Inc. | KZE |
| Dec 10, 1985 | K850754 | MEDAJET XL - JET INJECTOR Mada Medical Products, Inc. | KZE |
| Jul 5, 1985 | K844244 | DERATA MEDI-JECTOR PRO Derata Corp. | KZE |
| Jul 1, 1985 | K851809 | VACUUM COMPRESSION INJECTOR Uci Corp. | KZE |
| Jun 6, 1985 | K851181 | PRECI-JET 50 Ulster Scientific, Inc. | KZE |
| May 23, 1985 | K851029 | NEW VITAJET Andrew V. Stadler | KZE |
| Nov 28, 1984 | K844111 | DERATA MEDI-JECTOR III Derata Corp. | KZE |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.