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
53 devices
25–48 of 53
Cleared Nov 24, 1997
J-TIP INJECTOR
K973254
National Medical Products, Inc.
General Hospital · 87d
Cleared Mar 05, 1997
BIOJECTOR 2000 MODEL 1B02000
K960373
Bioject, Inc.
General Hospital · 404d
Cleared Dec 10, 1996
VITAJET
K962625
Vitajet Corp.
General Hospital · 158d
Cleared Oct 07, 1996
MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K962956
Medi-Ject Corp.
General Hospital · 69d
Cleared Apr 17, 1996
MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC
K960285
Medi-Ject Corp.
General Hospital · 89d
Cleared Nov 20, 1995
MEDIVAX
K945548
Vitajet Corp.
General Hospital · 371d
Cleared Aug 18, 1995
HYPEX(TM) JET INJECTOR
K945873
Equidyne Systems, Inc.
General Hospital · 260d
Cleared Jun 28, 1994
BIOJECT JET INJECTION SYSTEM
K920631
Bioject, Inc.
General Hospital · 867d
Cleared Nov 17, 1992
PRECI-JET 50
K921797
Hmi Industries, Inc.
General Hospital · 217d
Cleared Sep 30, 1992
OPHTHALMIC VISCOINJECTOR DRIVE
K923326
Synergetics, Inc.
General Hospital · 85d
Cleared Sep 16, 1991
MED-E-JET INJECTOR
K913018
Med-E-Jet D
General Hospital · 69d
Cleared Mar 15, 1991
INJECTOR, INSULIN
K905062
Sound 2000 Medical Systems, Inc.
General Hospital · 126d
Cleared May 07, 1990
VITAJET(INSULIN JET INJECTION DEVICE)
K893215
Vitajet Industriae Comercioltda.
General Hospital · 375d
Cleared Jun 29, 1987
ROBINJECT
K864984
International Medical Products, Inc.
General Hospital · 189d
Cleared Apr 23, 1987
BIOJECTOR SYRINGE SYSTEM
K861687
Bioject, Inc.
General Hospital · 356d
Cleared Feb 19, 1987
DERATA MEDI-JECTOR IV
K864561
Derata Corp.
General Hospital · 92d
Cleared Feb 03, 1987
INJET-100, FLUID INJECTOR
K861582
Injet Medical Products, Inc.
General Hospital · 280d
Cleared Jan 01, 1986
JECT-AID
K853031
Autoject Systems, Inc.
General Hospital · 167d
Cleared Jun 06, 1985
PRECI-JET 50
K851181
Ulster Scientific, Inc.
General Hospital · 73d