FDA Product Code
FDA Product Code KZE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5430
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K121270 | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM | Bioject Medical Technologies, Inc. | 2012-07-19 | Traditional | PDF ↗ |
| K111517 | PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI | Pharmajet, Inc. | 2011-07-27 | Special | PDF ↗ |
| K110456 | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | 2011-03-02 | Traditional | PDF ↗ |
| K090959 | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA | D'Antonio Consultants International, Inc. (Dci) | 2009-12-24 | Traditional | PDF ↗ |
| K090003 | ZETAJET | Bioject, Inc. | 2009-04-02 | Abbreviated | PDF ↗ |
| K081532 | PHARMAJET NEEDLE-FREE INJECTION SYSTEM | Pharmajet, Inc. | 2009-02-26 | Traditional | PDF ↗ |
| K082138 | AIRGENT, MODEL AG7000010 | Perfaction, Inc. | 2009-01-23 | Traditional | PDF ↗ |
| K060819 | COOL.CLICK 2 | Medical House Products Limited | 2006-06-16 | Traditional | PDF ↗ |
| K051985 | BIOVALVE MINI-JECT NEEDLEFREE INJECTOR | Biovalve Technologies, Inc. | 2005-08-17 | Special | PDF ↗ |
| K050734 | COOL.CLICK | Bioject, Inc. | 2005-06-03 | Traditional | PDF ↗ |
| K041239 | GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 | Genesis Medical Technology, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K041280 | HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 | Felton International, Inc. | 2004-06-24 | Special | PDF ↗ |
| K032976 | BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 | Biovalve Technologies, Inc. | 2004-04-16 | Traditional | PDF ↗ |
| K024018 | AVANT GUARDIAN 101 | Avant Medical Corporation | 2003-01-17 | Traditional | PDF ↗ |
| K020786 | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM | Rosch AG Medizintechnic | 2002-09-25 | Traditional | PDF ↗ |
| K022502 | INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 | Equidyne Systems, Inc. | 2002-09-05 | Traditional | PDF ↗ |
| K022148 | INJEX 30 NEEDLE FREE INJECTION SYSTEM | Equidyne Systems, Inc. | 2002-07-23 | Special | PDF ↗ |
| K013256 | BI-3M NEEDLE-FREE INJECTOR SYSTEM | Felton International, Inc. | 2001-12-07 | Traditional | PDF ↗ |
| K003741 | JET SYRINGE MODEL-100500 | Equidyne Systems, Inc. | 2001-06-01 | Traditional | PDF ↗ |
| K003908 | SEROJET | Bioject, Inc. | 2001-03-08 | Traditional | PDF ↗ |
| K003864 | INJEX 50 SYSTEM | Equidyne Systems, Inc. | 2001-03-06 | Traditional | PDF ↗ |
| K994384 | CLICKER | Bioject, Inc. | 2000-06-22 | Traditional | PDF ↗ |
| K991294 | MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM | Medi-Ject Corp. | 1999-04-23 | Special | PDF ↗ |
| K980082 | J-TIP NEEDLESS INJECTOR | National Medical Products, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K973254 | J-TIP INJECTOR | National Medical Products, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K960373 | BIOJECTOR 2000 MODEL 1B02000 | Bioject, Inc. | 1997-03-05 | Traditional | PDF ↗ |
| K962625 | VITAJET | Vitajet Corp. | 1996-12-10 | Traditional | PDF ↗ |
| K962956 | MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM | Medi-Ject Corp. | 1996-10-07 | Traditional | PDF ↗ |
| K960285 | MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC | Medi-Ject Corp. | 1996-04-17 | Traditional | PDF ↗ |
| K945548 | MEDIVAX | Vitajet Corp. | 1995-11-20 | Traditional | PDF ↗ |
| K945873 | HYPEX(TM) JET INJECTOR | Equidyne Systems, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K920631 | BIOJECT JET INJECTION SYSTEM | Bioject, Inc. | 1994-06-28 | Traditional | PDF ↗ |
| K921797 | PRECI-JET 50 | Hmi Industries, Inc. | 1992-11-17 | Traditional | PDF ↗ |
| K923326 | OPHTHALMIC VISCOINJECTOR DRIVE | Synergetics, Inc. | 1992-09-30 | Traditional | PDF ↗ |
| K913018 | MED-E-JET INJECTOR | Med-E-Jet D | 1991-09-16 | Traditional | PDF ↗ |
| K905062 | INJECTOR, INSULIN | Sound 2000 Medical Systems, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K893215 | VITAJET(INSULIN JET INJECTION DEVICE) | Vitajet Industriae Comercioltda. | 1990-05-07 | Traditional | PDF ↗ |
| K884293 | J-TIP INJECTOR SYSTEM | California Medical Innovations, Inc. | 1989-01-09 | Traditional | PDF ↗ |
| K883847 | DERATA MEDI-JECTOR V | Derata Corp. | 1988-10-31 | Traditional | PDF ↗ |
| K864984 | ROBINJECT | International Medical Products, Inc. | 1987-06-29 | Traditional | PDF ↗ |
| K861687 | BIOJECTOR SYRINGE SYSTEM | Bioject, Inc. | 1987-04-23 | Traditional | PDF ↗ |
| K864561 | DERATA MEDI-JECTOR IV | Derata Corp. | 1987-02-19 | Traditional | PDF ↗ |
| K861582 | INJET-100, FLUID INJECTOR | Injet Medical Products, Inc. | 1987-02-03 | Traditional | PDF ↗ |
| K853031 | JECT-AID | Autoject Systems, Inc. | 1986-01-01 | Traditional | PDF ↗ |
| K850754 | MEDAJET XL - JET INJECTOR | Mada Medical Products, Inc. | 1985-12-10 | Traditional | PDF ↗ |
| K844244 | DERATA MEDI-JECTOR PRO | Derata Corp. | 1985-07-05 | Traditional | PDF ↗ |
| K851809 | VACUUM COMPRESSION INJECTOR | Uci Corp. | 1985-07-01 | Traditional | PDF ↗ |
| K851181 | PRECI-JET 50 | Ulster Scientific, Inc. | 1985-06-06 | Traditional | PDF ↗ |
| K851029 | NEW VITAJET | Andrew V. Stadler | 1985-05-23 | Traditional | PDF ↗ |
| K844111 | DERATA MEDI-JECTOR III | Derata Corp. | 1984-11-28 | Traditional | PDF ↗ |
| K843784 | VITAJET JET INSULIN INJECTION DEVICE | Vitajet Industriae Comercioltda. | 1984-11-02 | Traditional | PDF ↗ |
| K834044 | MEDI-JECTOR II | Derata Corp. | 1984-03-06 | Traditional | PDF ↗ |
| K772129 | MEDI-JECTOR | Derata Corp. | 1977-12-08 | Traditional | PDF ↗ |
Product code KZE · Class II · General Hospital. Data: openFDA.