Safety-Ject, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Safety-Ject, Inc. makes
Safety-Ject, Inc. manufactures safety-engineered needles, including the PROGUARD II™ for injection use and the PROGUARD™ Blood Collection Needle designed for venipuncture procedures. These devices feature protective sheaths to reduce needle-stick injuries during use and disposal.
The company’s products fall under FDA Class II regulatory classification and are authorised via the 510(k) pathway. The devices are listed in the FDA’s 510(k) database. Safety-Ject, Inc. is based in the United States.
Catalogue
Proguard Ii(Tm) Ref K896086
Regimes: 510(k) Registry: 510(k)Proguard(Tm) Blood Collection Needle Ref K904295
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Safety-Ject, Inc. have in the registry?
The registry currently lists 2 devices for Safety-Ject, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Safety-Ject, Inc.'s devices?
Among its 2 most recently registered devices, Safety-Ject, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Safety-Ject, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Safety-Ject, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Safety-Ject, Inc. in the registry?
The most recently registered devices listed for Safety-Ject, Inc. include PROGUARD II(TM) and PROGUARD(TM) BLOOD COLLECTION NEEDLE.