HEMEDEX INCORPORATED

Matched from indexed company URL: HEMEDEX, INC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003730855	3003730855	HEMEDEX INCORPORATED	1	N	2026-01-01	564 Main Street Suite 300 North Waltham MA US 02452

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
59795	1441128248	K141869	QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT	GWM	2014-10-10
59795	1952436031	K013376	QFLOW 500 PERFUSION MONITORING SYSTEM	DPW	2002-05-08
59795	1502547794

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GWM	1	2014-10-10
DPW	1	2002-05-08

PMN#

QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT

2014-10-10

HEMEDEX INCORPORATED

HEMEDEX FIXATION DEVICE

2003-12-30

HEMEDEX INCORPORATED

HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

2003-10-21

HEMEDEX INCORPORATED

QFLOW 500 PERFUSION MONITORING SYSTEM

2002-05-08

HEMEDEX INCORPORATED

GUDID#

QFlow 500 2.7mm Drill Bit Kit - 2.7mm Drill Bit Kit

HEMEDEX, INC

2016-09-21

QFlow 500 5.3mm Drill Bit Kit - 5.3mm Drill Bit Kit

HEMEDEX, INC

2016-09-21

Bowman Perfusion Monitor, 120V - Perfusion Monitor, 120V

HEMEDEX, INC

2016-09-21

QFlow 500 Perfusion Probe - Thermal Diffusion Probe

HEMEDEX, INC

2016-09-21

QFlow 500 Titanium Bolt-Single Lumen - Intracranial Single Lumen Bolt

HEMEDEX, INC

2016-09-21

QFlow 500 Titanium Bolt-Dual Lumen - Intracranial dual lumen bolt

HEMEDEX, INC

2016-09-21

QFlow 500 Titanium Bolt-Single Lumen Bolt Kit - Intracranial Single Lumen Bolt Kit

HEMEDEX, INC

2016-09-21

QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit - Intracranial Dual Lumen Bolt Kit

HEMEDEX, INC

2016-09-21

QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer - Intracranial Dual lumen bolt kit with introducer

HEMEDEX, INC

2016-09-21

QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit - Intracranial Quad Lumen Bolt Kit

HEMEDEX, INC

2016-09-21

QFlow 500 Bolt Accessory Kit - Bolt Accessory Kit

HEMEDEX, INC

2016-09-23

QFlow 500 Probe Dura Piercer and Introducer Kit - Perfusion Probe Dura Piercer and Introducer Kit

HEMEDEX, INC

2016-09-21

QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Introducer - Probe Dura Piercer and Introducer Kit

HEMEDEX, INC

2016-09-21

QFlow 500 Male-Female Luer Coupler - Male-Female Luer Coupler

HEMEDEX, INC

2016-09-21

Bowman Perfusion Monitor, 240V - Perfusion Monitor, 240V

HEMEDEX, INC

2016-09-21