HEMEDEX INCORPORATED

FDA Device Registration & Listing · North Waltham, MA, US · Registration 3003730855

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003730855
FEI Number
3003730855
Entity Name
HEMEDEX INCORPORATED
City/State/Country
North Waltham, MA, US
Establishment Address
564 Main Street, Suite 300, North Waltham, MA 02452, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HEMEDEX INCORPORATED (Owner Number: 9048090)
Owner / Operator Contact Address
564 Main Street, Suite 300, Waltham, MA 02452, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K141869
PMA Number
N/A

All Registered Proprietary Names

QFLOW 500TM Accessories, Repositioning Sleeve QFLOW 500TM TITANIUM BOLT Single Lumen QFLOW 500TM TITANIUM BOLT Single Lumen Bolt Kit with Dura Piercer QFLOW 500TM Accessories, Touhy Borst / Compression Fitting 0-9 FR QFLOW 500TM Accessories, Bolt Accessories Kit QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit with Introducer QFLOW 500TM TITANIUM BOLT Quad Lumen Bolt Kit QFLOW 500TM TITANIUM BOLT Dual Lumen QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit QFLOW 500TM 5.3 mm Cranial Drill Bit QFLOW 500TM 2.7 mm Cranial Drill Bit QFLOW 500TM Accessories, Large Lumen Introducer QFLOW 500TM Accessories, Male Luer Coupler QFLOW 500TM Accessories, Male Luer Cap/Sealing Cap QFLOW 500TM Accessories, Probe Dura Piercer and Introducer Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2015-12-22
HBG Drills, Burrs, Trephines & Accessories (Manual) Neurology Class 2 882.4300 2014-12-16
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2014-12-16

Official Correspondent

Timothe Martin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HEMEDEX INCORPORATED
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K020558 Integra Neurosciences LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE 2002-03-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003730855. Last updated year: 2026. Please use registration number 3003730855 when referencing this establishment in official correspondence.
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