Hemedex Incorporated
United Statesfrom the FDA registration address FDA establishment FEI 3003730855
- Devices
- 19
- Registrations
- FDA
- FDA recalls
- 0
What Hemedex Incorporated makes
Hemedx Incorporated manufactures cranial fixation devices, including titanium bolts and quad-lumen bolt kits for neurosurgical applications, as well as perfusion monitoring systems for intracranial pressure assessment. Their product line also includes cranial bolt models for research and clinical use, alongside fixation hardware for securing monitoring equipment.
The company’s devices are classified as Class II under FDA regulations and are recorded in the 510(k) clearance database. These products are intended for use in the United States, where Hemedx Incorporated is based.
Catalogue
Search and filter all 19 devicesCompany details
- FDA FEI number
- 3003730855
- Address
- 564 Main Street, North Waltham, MA, 02452
Frequently asked questions
How many devices does HEMEDEX INCORPORATED have in the registry?
The registry currently lists 19 devices for HEMEDEX INCORPORATED. Devices recorded under merged duplicate company entries are counted once.
Which registries list HEMEDEX INCORPORATED's devices?
Among its 19 most recently registered devices, HEMEDEX INCORPORATED has devices listed in FDA 510(k) (4 devices) and FDA GUDID (15 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do HEMEDEX INCORPORATED's devices fall under?
Among its 19 most recently registered devices, the classes recorded for HEMEDEX INCORPORATED's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from HEMEDEX INCORPORATED in the registry?
The most recently registered devices listed for HEMEDEX INCORPORATED include QFlow 500 Perfusion Probe H0000-1600, QFlow 500 2.7mm Drill Bit Kit H0000-3611, QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit H0000-3644 and QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Introducer H0000-3684.