Data / Medical devices / United States / Hemedex Incorporated
Hemedex Incorporated: FDA-registered device maker in North Waltham, MA, United States, 2 510(k) clearances
Hemedex Incorporated is registered with the FDA (registration 3003730855) in North Waltham, MA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 10, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003730855
- Address
- 564 Main Street Suite 300, North Waltham, MA, United States, 02452
- Owner or operator
- HEMEDEX INCORPORATED (9048090)
- Roles
- Manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- Bowman Perfusion Monitor®, QFLOW 500TM 2.7 mm Cranial Drill Bit, QFLOW 500TM 5.3 mm Cranial Drill Bit, QFLOW 500TM Accessories, Bolt Accessories Kit, QFLOW 500TM Accessories, Large Lumen Introducer, QFLOW 500TM Accessories, Male Luer Cap/Sealing Cap, QFLOW 500TM Accessories, Male Luer Coupler, QFLOW 500TM Accessories, Probe Dura Piercer and Introducer Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Manufacturer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | 2 | Manufacturer | accessdata.fda.gov |
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 2014 | K141869 | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT | GWM | Substantially Equivalent | Hemedex Incorporated | accessdata.fda.gov |
| May 8, 2002 | K013376 | QFLOW 500 PERFUSION MONITORING SYSTEM | DPW | Substantially Equivalent | Hemedex Incorporated | accessdata.fda.gov |
Compare with other makers
- All makers of Drills, Burrs, Trephines & Accessories (Manual)
- All makers of Device, Monitoring, Intracranial Pressure
- All makers of Accessories, Catheter
- All makers of Flowmeter, Blood, Cardiovascular
Updated October 10, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.