FDA Product Code
FDA Product Code KZH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6920
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243232 | GripMate | Synthon Hispania S.L. | 2024-12-02 | Traditional | PDF ↗ |
| K213429 | AccuSert Needle Inserter | Emed Technologies Corporation | 2022-10-20 | Traditional | PDF ↗ |
| K163400 | Orbit Inserter | Ypsomed AG | 2017-07-26 | Traditional | PDF ↗ |
| K160860 | MiniMed Quick-serter | Medtronic Minimed | 2016-09-22 | Traditional | PDF ↗ |
| K141384 | WHISPERJECT AUTOINJECTOR | Scandinavian Health Limited | 2014-09-12 | Abbreviated | PDF ↗ |
| K124026 | LOBSTER AUTO-INJECTOR | Scandinavian Health Limited | 2013-09-13 | Traditional | PDF ↗ |
| K122837 | AUTOJECT 2 FOR GLASSY SYRINGE | Owen Mumford, Ltd. | 2012-10-15 | Special | PDF ↗ |
| K111467 | FLEXI-Q DV AND DVR AUTO-INJECTORS | Elcam Medical Acal | 2012-02-09 | Traditional | PDF ↗ |
| K082587 | AUTO-SAFETY INJECTOR-2 (ASI-2) | Medical House Products Limited | 2008-10-02 | Traditional | PDF ↗ |
| K073476 | COMPACT AUTO-SAFETY INJECTOR (CASI) | Medical House (Asi) Limited | 2008-03-07 | Traditional | PDF ↗ |
| K062339 | DERMOTHERAP GUN | Dermoequipos S.R.L. | 2007-02-05 | Traditional | PDF ↗ |
| K063146 | ACCU-CHEK LINKASSIST | Disetronic Medical Systems AG | 2006-11-27 | Traditional | PDF ↗ |
| K060141 | DAI-R | Shl Medical, USA | 2006-06-12 | Traditional | PDF ↗ |
| K060389 | CONFIDOSE IM AUTO-INJECTOR | Pharma-Pen, Inc. | 2006-06-06 | Traditional | PDF ↗ |
| K051667 | EZ-JECT | Indolor, Ltd. | 2005-09-27 | Traditional | PDF ↗ |
| K050434 | SHL DISPOSABLE AUTOINJECTOR | Shl Medical, USA | 2005-06-24 | Traditional | PDF ↗ |
| K033696 | PERSONAL INJECTOR | Union Medico Aps | 2005-02-16 | Traditional | PDF ↗ |
| K042557 | INNOJECT AUTO-INJECTOR | Innoject, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K032848 | MEDSAFE SYSTEM INSERTER | Medsolve Technologies, LLC | 2004-04-12 | Traditional | PDF ↗ |
| K032425 | INVISIJECT RESUSABLE AUTO-INJECTOR | Biogen | 2003-11-05 | Traditional | PDF ↗ |
| K021700 | ANIMUS EZSERTER INFUSION SET INSERTER | Animas Corp. | 2002-06-04 | Traditional | PDF ↗ |
| K013362 | AUTOJECT 2 | Owen Mumford USA, Inc. | 2001-11-13 | Traditional | PDF ↗ |
| K010377 | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 | Minimed, Inc. | 2001-04-05 | Traditional | PDF ↗ |
| K000482 | MODIFICATION TO AUTOJECT MINI | Owen Mumford, Ltd. | 2000-03-06 | Traditional | PDF ↗ |
| K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) | Owen Mumford USA, Inc. | 1999-11-10 | Traditional | PDF ↗ |
| K992300 | QUICK-SERTER, MODEL 395 | Medtronic Minimed | 1999-07-29 | Traditional | PDF ↗ |
| K991680 | SOFTINJECT | Androsystems Srl | 1999-06-03 | Traditional | PDF ↗ |
| K981266 | AUTO-INJECTOR, SURE-INJECT 2000 | Mighty Mo, Corp. | 1998-07-14 | Traditional | PDF ↗ |
| K974678 | B-D AUTO-INJECTOR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-05-29 | Traditional | PDF ↗ |
| K974171 | COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS | Teva Medical, Ltd. | 1997-12-19 | Traditional | PDF ↗ |
| K970479 | MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 | Medtronic Minimed | 1997-03-31 | Traditional | PDF ↗ |
| K961309 | POS-T-VAC ID-300 | Pos-T-Vac, Inc. | 1996-06-10 | Traditional | PDF ↗ |
| K954729 | PEN-INJECT 2.25 | Scandinavian Health , Ltd. | 1996-01-29 | Traditional | PDF ↗ |
| K953735 | AUTOJECT MINI | Owen Mumford USA, Inc. | 1995-11-08 | Traditional | PDF ↗ |
| K945660 | AUTOJECT 2 | Owen Mumford USA, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K951384 | V-CATH PERCUTANEOUS INTRODUCER KIT | Hdc Corp. | 1995-06-23 | Traditional | PDF ↗ |
| K945473 | V-CATH BREAKAWAY NEEDLE INTRODUCER | Hdc Corp. | 1995-01-20 | Traditional | PDF ↗ |
| K901803 | SYRINGE NEEDLE INTRODUCER | Glaxo, Inc. | 1990-11-20 | Traditional | PDF ↗ |
| K883164 | INSTAJECT II | Pavel Jordan & Associates, Inc. | 1988-10-04 | Traditional | PDF ↗ |
| K872233 | INJECT-EASE | Palco Laboratories, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K870474 | INSTAJECT | Pavel Jordan & Associates, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K862325 | THE INJECTOR | American Medical Innovations, Inc. | 1987-02-27 | Traditional | PDF ↗ |
| K860284 | DIAMATIC, AUTOMATIC INSULIN INJECTOR | Ulster Scientific, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K832847 | MEDI-JECT | Jack H. Ritterskamp | 1984-02-28 | Traditional | PDF ↗ |
| K834440 | INJECTION AIDE UNIT FOR DIAGETICS | Gottinger Co. | 1984-02-04 | Traditional | PDF ↗ |
| K832683 | MONOJECT INJECTOMATIC | Sherwood Medical Co. | 1983-09-12 | Traditional | PDF ↗ |
| K790104 | PISTORMATIC | Zelby, Burstein, Hartman & Burstein | 1979-05-14 | Traditional | PDF ↗ |
Product code KZH · Class II · General Hospital. Data: openFDA.