Introducer, Syringe Needle

FDA product code KZH · 46 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.6920
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-05-14 – 2024-12-02

KZH 2024-12-02

GripMate

Applicant Synthon Hispania S.L.

K number K243232

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KZH 2022-10-20

AccuSert Needle Inserter

Applicant Emed Technologies Corporation

K number K213429

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KZH 2017-07-26

Orbit Inserter

Applicant Ypsomed AG

K number K163400

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KZH 2016-09-22

MiniMed Quick-serter

Applicant Medtronic Minimed

K number K160860

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KZH 2013-09-13

LOBSTER AUTO-INJECTOR

Applicant Scandinavian Health Limited

K number K124026

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KZH 2012-10-15

AUTOJECT 2 FOR GLASSY SYRINGE

Applicant Owen Mumford, Ltd.

K number K122837

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KZH 2012-02-09

FLEXI-Q DV AND DVR AUTO-INJECTORS

Applicant Elcam Medical Acal

K number K111467

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KZH 2008-10-02

AUTO-SAFETY INJECTOR-2 (ASI-2)

Applicant Medical House Products Limited

K number K082587

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KZH 2008-03-07

COMPACT AUTO-SAFETY INJECTOR (CASI)

Applicant Medical House (Asi) Limited

K number K073476

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KZH 2007-02-05

DERMOTHERAP GUN

Applicant Dermoequipos S.R.L.

K number K062339

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KZH 2006-11-27

ACCU-CHEK LINKASSIST

Applicant Disetronic Medical Systems AG

K number K063146

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KZH 2006-06-12

DAI-R

Applicant Shl Medical, USA

K number K060141

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KZH 2006-06-06

CONFIDOSE IM AUTO-INJECTOR

Applicant Pharma-Pen, Inc.

K number K060389

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KZH 2005-09-27

EZ-JECT

Applicant Indolor, Ltd.

K number K051667

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KZH 2005-06-24

SHL DISPOSABLE AUTOINJECTOR

Applicant Shl Medical, USA

K number K050434

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KZH 2005-02-16

PERSONAL INJECTOR

Applicant Union Medico Aps

K number K033696

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KZH 2004-11-08

INNOJECT AUTO-INJECTOR

Applicant Innoject, Inc.

K number K042557

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KZH 2004-04-12

MEDSAFE SYSTEM INSERTER

Applicant Medsolve Technologies, LLC

K number K032848

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KZH 2003-11-05

INVISIJECT RESUSABLE AUTO-INJECTOR

Applicant Biogen

K number K032425

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KZH 2002-06-04

ANIMUS EZSERTER INFUSION SET INSERTER

Applicant Animas Corp.

K number K021700

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KZH 2001-11-13

AUTOJECT 2

Applicant Owen Mumford USA, Inc.

K number K013362

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KZH 2001-04-05

MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385

Applicant Minimed, Inc.

K number K010377

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KZH 2000-03-06

MODIFICATION TO AUTOJECT MINI

Applicant Owen Mumford, Ltd.

K number K000482

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KZH 1999-11-10

AUTOJET 2 (NON-FIXED NEEDLE TYPE)

Applicant Owen Mumford USA, Inc.

K number K993385

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KZH 1999-07-29

QUICK-SERTER, MODEL 395

Applicant Medtronic Minimed

K number K992300

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KZH 1999-06-03

SOFTINJECT

Applicant Androsystems Srl

K number K991680

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KZH 1998-07-14

AUTO-INJECTOR, SURE-INJECT 2000

Applicant Mighty Mo, Corp.

K number K981266

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KZH 1998-05-29

B-D AUTO-INJECTOR

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K974678

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KZH 1997-12-19

COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS

Applicant Teva Medical, Ltd.

K number K974171

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KZH 1997-03-31

MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300

Applicant Medtronic Minimed

K number K970479

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KZH 1996-06-10

POS-T-VAC ID-300

Applicant Pos-T-Vac, Inc.

K number K961309

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KZH 1996-01-29

PEN-INJECT 2.25

Applicant Scandinavian Health , Ltd.

K number K954729

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KZH 1995-11-08

AUTOJECT MINI

Applicant Owen Mumford USA, Inc.

K number K953735

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KZH 1995-08-11

AUTOJECT 2

Applicant Owen Mumford USA, Inc.

K number K945660

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KZH 1995-06-23

V-CATH PERCUTANEOUS INTRODUCER KIT

Applicant Hdc Corp.

K number K951384

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KZH 1995-01-20

V-CATH BREAKAWAY NEEDLE INTRODUCER

Applicant Hdc Corp.

K number K945473

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KZH 1990-11-20

SYRINGE NEEDLE INTRODUCER

Applicant Glaxo, Inc.

K number K901803

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KZH 1988-10-04

INSTAJECT II

Applicant Pavel Jordan & Associates, Inc.

K number K883164

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KZH 1987-09-04

INJECT-EASE

Applicant Palco Laboratories, Inc.

K number K872233

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KZH 1987-03-13

INSTAJECT

Applicant Pavel Jordan & Associates, Inc.

K number K870474

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KZH 1987-02-27

THE INJECTOR

Applicant American Medical Innovations, Inc.

K number K862325

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KZH 1986-04-07

DIAMATIC, AUTOMATIC INSULIN INJECTOR

Applicant Ulster Scientific, Inc.

K number K860284

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KZH 1984-02-28

MEDI-JECT

Applicant Jack H. Ritterskamp

K number K832847

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KZH 1984-02-04

INJECTION AIDE UNIT FOR DIAGETICS

Applicant Gottinger Co.

K number K834440

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KZH 1983-09-12

MONOJECT INJECTOMATIC

Applicant Sherwood Medical Co.

K number K832683

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KZH 1979-05-14

PISTORMATIC

Applicant Zelby, Burstein, Hartman & Burstein

K number K790104

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