KZE · Class II · 21 CFR 880.5430

FDA Product Code KZE: Injector, Fluid, Non-electrically Powered

Leading manufacturers include Bioject, Inc., Equidyne Systems, Inc. and Medi-Ject Corp..

53
Total
53
Cleared
148d
Avg days
1977
Since

FDA 510(k) Cleared Injector, Fluid, Non-electrically Powered Devices (Product Code KZE)

53 devices
1–24 of 53
Cleared Jul 19, 2012
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
K121270
Bioject Medical Technologies, Inc.
General Hospital · 84d
Cleared Jul 27, 2011
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
K111517
Pharmajet, Inc.
General Hospital · 55d
Cleared Mar 02, 2011
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
K110456
Pharmajet, Inc.
General Hospital · 14d
Cleared Dec 24, 2009
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
K090959
D'Antonio Consultants International, Inc. (Dci)
General Hospital · 262d
Cleared Apr 02, 2009
ZETAJET
K090003
Bioject, Inc.
General Hospital · 90d
Cleared Feb 26, 2009
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
K081532
Pharmajet, Inc.
General Hospital · 269d
Cleared Jan 23, 2009
AIRGENT, MODEL AG7000010
K082138
Perfaction, Inc.
General Hospital · 178d
Cleared Jun 16, 2006
COOL.CLICK 2
K060819
Medical House Products Limited
General Hospital · 81d
Cleared Aug 17, 2005
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
K051985
Biovalve Technologies, Inc.
General Hospital · 26d
Cleared Jun 03, 2005
COOL.CLICK
K050734
Bioject, Inc.
General Hospital · 74d
Cleared Nov 08, 2004
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
K041239
Genesis Medical Technology, Inc.
General Hospital · 181d
Cleared Jun 24, 2004
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
K041280
Felton International, Inc.
General Hospital · 42d
Cleared Apr 16, 2004
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
K032976
Biovalve Technologies, Inc.
General Hospital · 205d
Cleared Jan 17, 2003
AVANT GUARDIAN 101
K024018
Avant Medical Corporation
General Hospital · 44d
Cleared Sep 25, 2002
INJEX NEEDLE-FREE INJECTION SYSTEM
K020786
Rosch AG Medizintechnic
General Hospital · 198d
Cleared Sep 05, 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
K022502
Equidyne Systems, Inc.
General Hospital · 38d
Cleared Jul 23, 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM
K022148
Equidyne Systems, Inc.
General Hospital · 21d
Cleared Dec 07, 2001
BI-3M NEEDLE-FREE INJECTOR SYSTEM
K013256
Felton International, Inc.
General Hospital · 67d
Cleared Jun 01, 2001
JET SYRINGE MODEL-100500
K003741
Equidyne Systems, Inc.
General Hospital · 179d
Cleared Mar 08, 2001
SEROJET
K003908
Bioject, Inc.
General Hospital · 79d
Cleared Mar 06, 2001
INJEX 50 SYSTEM
K003864
Equidyne Systems, Inc.
General Hospital · 83d
Cleared Jun 22, 2000
CLICKER
K994384
Bioject, Inc.
General Hospital · 177d
Cleared Apr 23, 1999
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K991294
Medi-Ject Corp.
General Hospital · 8d
Cleared Mar 04, 1998
J-TIP NEEDLESS INJECTOR
K980082
National Medical Products, Inc.
General Hospital · 54d

About Product Code KZE - Regulatory Context