Panels › General Hospital › Product code KZH · Class 2
Introducer, Syringe Needle
Regulation 880.6920
0510(k)s in 12 months (47 all time)
0recalls in 12 months (10 all time)
8recalls that name a 510(k)
Top companies in KZH
| Company | 510(k)s | Recalls |
|---|---|---|
| Owen Mumford USA, Inc. | 6 | 3 |
| Arrow International Inc | 0 | 4 |
| Medtronic Minimed | 3 | 0 |
| Scandinavian Health , Ltd. | 3 | 0 |
| Hdc Corp. | 2 | 0 |
| Pavel Jordan & Associates, Inc. | 2 | 0 |
| Shl Medical, USA | 2 | 0 |
| American Medical Innovations, Inc. | 1 | 0 |
| Androsystems Srl | 1 | 0 |
| Animas Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 2024 | K243232 | GripMate Synthon Hispania S.L., ES | KZH |
| Oct 20, 2022 | K213429 | AccuSert Needle Inserter Emed Technologies Corporation | KZH |
| Jul 26, 2017 | K163400 | Orbit Inserter Ypsomed AG, CH | KZH |
| Sep 22, 2016 | K160860 | MiniMed Quick-serter Medtronic Minimed | KZH |
| Sep 12, 2014 | K141384 | WHISPERJECT AUTOINJECTOR Scandinavian Health Limited | KZH |
| Sep 13, 2013 | K124026 | LOBSTER AUTO-INJECTOR Scandinavian Health Limited | KZH |
| Oct 15, 2012 | K122837 | AUTOJECT 2 FOR GLASSY SYRINGE Owen Mumford, Ltd., GB | KZH |
| Feb 9, 2012 | K111467 | FLEXI-Q DV AND DVR AUTO-INJECTORS Elcam Medical Acal, IL | KZH |
| Oct 2, 2008 | K082587 | AUTO-SAFETY INJECTOR-2 (ASI-2) Medical House Products Limited, GB | KZH |
| Mar 7, 2008 | K073476 | COMPACT AUTO-SAFETY INJECTOR (CASI) Medical House (Asi) Limited, GB | KZH |
| Feb 5, 2007 | K062339 | DERMOTHERAP GUN Dermoequipos S.R.L., IL | KZH |
| Nov 27, 2006 | K063146 | ACCU-CHEK LINKASSIST Disetronic Medical Systems AG | KZH |
| Jun 12, 2006 | K060141 | DAI-R Shl Medical, USA | KZH |
| Jun 6, 2006 | K060389 | CONFIDOSE IM AUTO-INJECTOR Pharma-Pen, Inc. | KZH |
| Sep 27, 2005 | K051667 | EZ-JECT Indolor, Ltd. | KZH |
| Jun 24, 2005 | K050434 | SHL DISPOSABLE AUTOINJECTOR Shl Medical, USA | KZH |
| Feb 16, 2005 | K033696 | PERSONAL INJECTOR Union Medico Aps, DK | KZH |
| Nov 8, 2004 | K042557 | INNOJECT AUTO-INJECTOR Innoject, Inc. | KZH |
| Apr 12, 2004 | K032848 | MEDSAFE SYSTEM INSERTER Medsolve Technologies, LLC | KZH |
| Nov 5, 2003 | K032425 | INVISIJECT RESUSABLE AUTO-INJECTOR Biogen | KZH |
| Jun 4, 2002 | K021700 | ANIMUS EZSERTER INFUSION SET INSERTER Animas Corp. | KZH |
| Nov 13, 2001 | K013362 | AUTOJECT 2 Owen Mumford USA, Inc. | KZH |
| Apr 5, 2001 | K010377 | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 Minimed, Inc. | KZH |
| Mar 6, 2000 | K000482 | MODIFICATION TO AUTOJECT MINI Owen Mumford, Ltd. | KZH |
| Nov 10, 1999 | K993385 | AUTOJET 2 (NON-FIXED NEEDLE TYPE) Owen Mumford USA, Inc. | KZH |
| Jul 29, 1999 | K992300 | QUICK-SERTER, MODEL 395 Medtronic Minimed | KZH |
| Jun 3, 1999 | K991680 | SOFTINJECT Androsystems Srl, IT | KZH |
| Jul 14, 1998 | K981266 | AUTO-INJECTOR, SURE-INJECT 2000 Mighty Mo, Corp. | KZH |
| May 29, 1998 | K974678 | B-D AUTO-INJECTOR Bd Becton Dickinson Vacutainer Systems Preanalytic | KZH |
| Dec 19, 1997 | K974171 | COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS Teva Medical, Ltd. | KZH |
| Mar 31, 1997 | K970479 | MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 Medtronic Minimed | KZH |
| Jun 10, 1996 | K961309 | POS-T-VAC ID-300 Pos-T-Vac, Inc. | KZH |
| Jan 29, 1996 | K954729 | PEN-INJECT 2.25 Scandinavian Health , Ltd. | KZH |
| Nov 8, 1995 | K953735 | AUTOJECT MINI Owen Mumford USA, Inc. | KZH |
| Aug 11, 1995 | K945660 | AUTOJECT 2 Owen Mumford USA, Inc. | KZH |
| Jun 23, 1995 | K951384 | V-CATH PERCUTANEOUS INTRODUCER KIT Hdc Corp. | KZH |
| Jan 20, 1995 | K945473 | V-CATH BREAKAWAY NEEDLE INTRODUCER Hdc Corp. | KZH |
| Nov 20, 1990 | K901803 | SYRINGE NEEDLE INTRODUCER Glaxo, Inc. | KZH |
| Oct 4, 1988 | K883164 | INSTAJECT II Pavel Jordan & Associates, Inc. | KZH |
| Sep 4, 1987 | K872233 | INJECT-EASE Palco Laboratories, Inc. | KZH |
| Mar 13, 1987 | K870474 | INSTAJECT Pavel Jordan & Associates, Inc. | KZH |
| Feb 27, 1987 | K862325 | THE INJECTOR American Medical Innovations, Inc. | KZH |
| Apr 7, 1986 | K860284 | DIAMATIC, AUTOMATIC INSULIN INJECTOR Ulster Scientific, Inc. | KZH |
| Feb 28, 1984 | K832847 | MEDI-JECT Jack H. Ritterskamp | KZH |
| Feb 4, 1984 | K834440 | INJECTION AIDE UNIT FOR DIAGETICS Gottinger Co. | KZH |
| Sep 12, 1983 | K832683 | MONOJECT INJECTOMATIC Sherwood Medical Co. | KZH |
| May 14, 1979 | K790104 | PISTORMATIC Zelby, Burstein, Hartman & Burstein | KZH |
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