Hemedex Inc

FDA Filings

This page includes the latest FDA filings for Hemedex Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003730855
• FEI Number: 3003730855
• Name: HEMEDEX INCORPORATED
• Owner & Operator: HEMEDEX INCORPORATED
• Contact Address: 564 Main Street Suite 300; Waltham MA 02452 US
• Official Correspondent:
  • Stefanie - Cantin
  • x-617-5771759-104
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 564 Main Street Suite 300; North Waltham, MA 02452 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID B238H000036120 HEMEDEX, INC	QFlow 500 5.3mm Drill Bit Kit H0000-3612	2018-11-22
GUDID B238H000036110 HEMEDEX, INC	QFlow 500 2.7mm Drill Bit Kit H0000-3611	2018-11-22
GUDID B238H000107110 HEMEDEX, INC	Bowman Perfusion Monitor, 240V H0001-0711	2018-07-06
GUDID B238H000036850 HEMEDEX, INC	QFlow 500 Male-Female Luer Coupler H0000-3685	2018-07-06
GUDID B238H000036840 HEMEDEX, INC	QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Intr H0000-3684	2018-07-06
GUDID B238H000036830 HEMEDEX, INC	QFlow 500 Probe Dura Piercer and Introducer Kit H0000-3683	2018-07-06
GUDID B238H000036810 HEMEDEX, INC	QFlow 500 Bolt Accessory Kit H0000-3681	2018-07-06
GUDID B238H000036440 HEMEDEX, INC	QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit H0000-3644	2018-07-06
GUDID B238H000036420 HEMEDEX, INC	QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with I H0000-3642	2018-07-06
GUDID B238H000036320 HEMEDEX, INC	QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit H0000-3632	2018-07-06
GUDID B238H000036310 HEMEDEX, INC	QFlow 500 Titanium Bolt-Single Lumen Bolt Kit H0000-3631	2018-07-06
GUDID B238H000036020 HEMEDEX, INC	QFlow 500 Titanium Bolt-Dual Lumen H0000-3602	2018-07-06
GUDID B238H000036010 HEMEDEX, INC	QFlow 500 Titanium Bolt-Single Lumen H0000-3601	2018-07-06
GUDID B238H000016000 HEMEDEX, INC	QFlow 500 Perfusion Probe H0000-1600	2018-07-06
GUDID B238H000007100 HEMEDEX, INC	Bowman Perfusion Monitor, 120V H0000-0710	2018-07-06
KGZ HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Repositioning Sleeve	2015-12-22
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Single Lumen	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Single Lumen Bolt Kit with Dura Piercer	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Quad Lumen Bolt Kit	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Dual Lumen	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit with Introducer	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Touhy Borst / Compression Fitting 0-9 FR	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Probe Dura Piercer and Introducer Kit	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Male Luer Coupler	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Male Luer Cap/Sealing Cap	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Large Lumen Introducer	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Bolt Accessories Kit	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM 5.3 mm Cranial Drill Bit	2014-12-16
PMN K141869 | HBG HEMEDEX INCORPORATED	QFLOW 500TM 2.7 mm Cranial Drill Bit	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Single Lumen	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Single Lumen Bolt Kit with Dura Piercer	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Quad Lumen Bolt Kit	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Dual Lumen	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit with Introducer	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Touhy Borst / Compression Fitting 0-9 FR	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Probe Dura Piercer and Introducer Kit	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Male Luer Coupler	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Male Luer Cap/Sealing Cap	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Large Lumen Introducer	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM Accessories, Bolt Accessories Kit	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM 5.3 mm Cranial Drill Bit	2014-12-16
PMN K141869 | GWM HEMEDEX INCORPORATED	QFLOW 500TM 2.7 mm Cranial Drill Bit	2014-12-16
PMN K141869 HEMEDEX INCORPORATED	QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT	2014-10-10
PMN K013376 | DPW HEMEDEX INCORPORATED	QFLOW 500TM Perfusion Probe	2007-12-10
PMN K013376 | DPW HEMEDEX INCORPORATED	Bowman Perfusion Monitor?	2007-12-10
PMN K032127 HEMEDEX INCORPORATED	HEMEDEX FIXATION DEVICE	2003-12-30
PMN K032337 HEMEDEX INCORPORATED	HEMEDEX CRANIAL BOLT MODELS, 3601, 3602	2003-10-21
PMN K013376 HEMEDEX INCORPORATED	QFLOW 500 PERFUSION MONITORING SYSTEM	2002-05-08

Related Finance Registrations

NCAGE Code	4FJJ6	HEMEDEX, INC
CAGE Code	4FJJ6	HEMEDEX, INC
S.A.M. Registration	4FJJ6 [128045676]	HEMEDEX, INC
DUNS	128045676	Hemedex, Inc