101 results
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25ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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Hygie Canada Inc
System producer
🇨🇦 Canada
Front Line Medical Technologies Inc.
System producer
🇨🇦 Canada
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
FDA Enforcement
Class I
·Ongoing·Kinova Inc·October 23, 2024
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
FDA Enforcement
Class II
·Terminated·Epocal Inc·July 25, 2012
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
FDA Enforcement
Class II
·Terminated·Benlan, Inc.·January 13, 2016
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
FDA Enforcement
Class II
·Terminated·Southmedic, Inc.·April 11, 2018
MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
FDA Enforcement
Class II
·Terminated·Wescam Inc·July 25, 2018
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
FDA Enforcement
Class II
·Terminated·Southmedic, Inc.·May 23, 2018
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Enforcement
Class III
·Terminated·Theralase Inc.·December 11, 2019
TLC-2000 Therapeutic Medical Laser System
FDA Enforcement
Class III
·Terminated·Theralase Inc.·March 4, 2020
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
FDA Enforcement
Class III
·Terminated·Theralase Inc.·March 4, 2020
TLC-2000 Therapeutic Medical Laser System
FDA Enforcement
Class III
·Terminated·Theralase Inc.·February 26, 2020
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Enforcement
Class III
·Terminated·Theralase Inc.·December 11, 2019
TLC-2000 Therapeutic Medical Laser System
FDA Enforcement
Class III
·Terminated·Theralase Inc.·March 4, 2020
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
FDA Enforcement
Class III
·Terminated·Theralase Inc.·February 26, 2020
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
FDA Enforcement
Class II
·Terminated·MY01, INC.·September 8, 2021
OxyMask O2 Adult REF OM-1125-14
FDA Enforcement
Class II
·Ongoing·Southmedic, Inc.·August 4, 2021
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
FDA Enforcement
Class II
·Ongoing·Southmedic, Inc.·November 30, 2022
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
FDA Enforcement
Class II
·Terminated·Diagnos Inc·April 6, 2022
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·June 24, 2026