FDA.reportPublic FDA data

MedXL

Matched from indexed company URL: MEDX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16443121000117748MedXL1N2026-01-013204 Hale Rd ARDMORE OK US 73401
30037251903003725190MedX Health Corp.1N2026-01-011495 Bonhill Road Unit 1 MISSISSAUGA Ontario CA L5T 1M2
30096170153009617015MEDXPERT NORTH AMERICA1Y2020-04-252500 S Broadway Ste 250 Suite 250 Edmond OK US 73013

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00628451918288MedX Rehab Console - The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical device accessories like the Multi-cluster, tethered MCT1001, Laser cluster, tethered LCT450 and Laser probe, tethered LPT 200. It is the main reference for identification and traceability, and part of the kit for MedX Health Item numbers #3110, #3114, #3116, #3120, and #3122. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.1 905 670 4428tobillo@medxhealth.com
00628451918318MedX Oralase Tethered Laser - The MedX Oralase tethered laser medical device or LPT200 is part of the kit for MedX Health item numbers #3120 and #3122. It is controlled and powered by MedX Rehab Console MBM1100N. This product is registered for the purpose showing its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.1 905 670 4428tobillo@medxhealth.com
00628451918318MedX Oralase Tethered Laser - The MedX Oralase tethered laser medical device or LPT200 is part of the kit for MedX Health item numbers #3120 and #3122. It is controlled and powered by MedX Rehab Console MBM1100N. This product is registered for the purpose showing its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.9056704428eugen.kiss@medxhealth.com
10682686004472Praxiject™ 0.9% NaCl - 5 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe+1.514.695.7474na@medxl.com
10682686004472Praxiject™ 0.9% NaCl - 5 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe+1.514.695.7474sales@medxl.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
204891317247219K082707MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASERILY2008-10-01
204891039610978K062736SIASCOPE VPSN2007-09-14
204891041756525K050022MEDX HOMEILY2005-05-05
204891671983696K032231MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASERILY2003-10-03
204891562178084K024310NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORYNHN2003-03-24
204891531180906K021985MEDX LCS LASER SERIESNHN2002-09-10
204891359262099K020017MEDX 1000 SERIESILY2002-07-12
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Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ILY72008-10-01
PSN22007-09-14
NHN22003-03-24

PMN#

GUDID#

MedX Rehab Console - The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical device accessories like the Multi-cluster, tethered MCT1001, Laser cluster, tethered LCT450 and Laser probe, tethered LPT 200. It is the main reference for identification and traceability, and part of the kit for MedX Health Item numbers #3110, #3114, #3116, #3120, and #3122. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.

MedX Health Corp

2018-10-17

SLD Light cluster - The MedX SLD Light diode Cluster, with an output power of 500mW, is used together with the Richmar console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated.This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.

MedX Health Corp

2018-11-06

MedX Rehab Portable Laser - The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser medical device accessory and is part of MedX Health kit Item # 0915. The hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. ) This registration is to show the UDI for direct marking and primary packaging when this product shipped as a particular item, e.g. replacement or repaired unit, and not as a kit.

MedX Health Corp

2018-10-18

MedX SLD Light Cluster - The MedX SLD Light diode Cluster is used together with the MedX Home console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated.

MedX Health Corp

2016-09-24

MedX Rehab Tethered Laser - The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (LLLT) device for use to treat a wide variety of medical conditions. It is also used for treating deeper tissue conditions. This accessory contains three SLD near-infrared laser light diodes for therapeutic applications and a visible LED guide light. It is part of the kit for MedX Health Items #3114, #3116.LCT 450 is controlled and powered by MedX Rehab console 1100N. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.

MedX Health Corp

2016-09-24

MedX SLD Light Cluster - The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapped to the body for “hands-free”, unattended treatment. The accessory contains a large number of Light emitting diodes that are used to treat a variety of medical conditions such as swelling, inflammation, pain, bruising, wound healing and many other medical conditions.This laser medical device accessory is controlled and powered by MBM 1100N. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.

MedX Health Corp

2016-09-24

MedX Rehab Portable Laser - The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.

MedX Health Corp

2018-10-31

MedX Oralase Portable Laser - The Oralase Portable Laser, LPS200, delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. This device is the main reference for identification and traceability for MedX Health kit Item# 0910 This product is registered to show its UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.

MedX Health Corp

2018-10-18

MedX Oralase Console System - The MedX Oralase Console system is a therapeutic Low-Level Laser and Light therapy system for Oralase application. It features a handheld laser device which provides low level laser therapy to a smaller focused treatment area. The single near-infra-red laser diode tip has a visible LED guide light and can be used with either the intra-oral or extra-oral light guides. The MedX 1100N console powers the handheld laser therapy device and also two SLD accessories. The MedX SLD Light cluster accessory offers light therapy for broader treatment applications. This accessory can be strapped to the body for “hands-free” unattended treatment.

MedX Health Corp

2017-12-22

MedX Rehab Portable Laser - The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.

MedX Health Corp

2016-09-24

MedX Rehab Console System - "The MedX Rehab Console System is a therapeutic Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruising, wound healing and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers the high quality handheld laser therapy device and also two SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader treatment applications. This accessory can be strapped to the body for ""hands-free"" unattended treatment. "

MedX Health Corp

2016-09-24

MedX Rehab Console System - "The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruise and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers three SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader variety of applications. This Cluster accessories can be strapped to the body for ""hands-free"" unattended treatment."

MedX Health Corp

2016-09-24

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