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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2019 | Owen Mumford USA, Inc. Petfine Auto Injector, REF 3310VET Open, Classified |
KZH | K945660 |
| Jul 17, 2019 | Owen Mumford USA, Inc. Autoject EI, REF AJ1310 Open, Classified |
KZH | K945660 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Syringe Bulb, 60 CC 50 pcs per case.
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in t Terminated |
KZH | None listed |
| Apr 2, 2015 | Owen Mumford USA, Inc. Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010
The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor. Terminated |
KZH | K945660 |
| Nov 7, 2011 | Becton Dickinson & Company 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920
Intended use: Subcutaneous injection of insulin. Terminated |
KZH | K024112 |
| Apr 8, 2005 | Tri-State Hospital Supply Corp Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S. Terminated |
KZH | None listed |
| Nov 1, 2003 | Arrow International Inc 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set Terminated |
KZH | K924607 |
| Nov 1, 2003 | Arrow International Inc Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm Terminated |
KZH | K010399 |
| Nov 1, 2003 | Arrow International Inc Arrow central venous catheterization kit, 14 ga x 20 cm Terminated |
KZH | K862056 |
| Nov 1, 2003 | Arrow International Inc Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm Terminated |
KZH | K900263 |
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