Gerard Medical Enterprises, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Gerard Medical Enterprises, Inc. makes
Gerard Medical Enterprises, Inc. manufactures vascular access systems, including dual plastic and implantable titanium-port variants designed for long-term intravenous access. Their portfolio also includes a dedicated electrode tester for medical device functionality verification and multiple configurations of the TRIMPORT implantable access system, which supports dual-lumen access.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates from the United States, with its products authorised for commercial distribution in the US market.
Catalogue
Dual Plastic Vascular Access System Ref K922147
Regimes: 510(k) Registry: 510(k)Gerard Medical, Inc. Trim-Port Ref K903364
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Trimport Ref K942623
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Trimport Ref K945250
Regimes: 510(k) Registry: 510(k)Gerard Medical Electrode Tester Ref K813358
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gerard Medical Enterprises, Inc. have in the registry?
The registry currently lists 8 devices for Gerard Medical Enterprises, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gerard Medical Enterprises, Inc.'s devices?
Among its 8 most recently registered devices, Gerard Medical Enterprises, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Gerard Medical Enterprises, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Gerard Medical Enterprises, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gerard Medical Enterprises, Inc. in the registry?
The most recently registered devices listed for Gerard Medical Enterprises, Inc. include DUAL PLASTIC VASCULAR ACCESS SYSTEM, GERARD MEDICAL, INC. TRIM-PORT, MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE and TRIMPORT.