17 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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RAPID AID CORP.
FDA registration
RAPID AID CORP.·6 products·🇨🇦 Canada
SAFECROSS FIRST AID LTD.
FDA registration
SAFECROSS FIRST AID LTD.·2 products·🇨🇦 Canada
TEX-AID BLUE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERI-AID KIT
FDA 510(k)
FDA Class 1
·General Hospital
GAIT-AID ORTHOPEDIC INSOLE
FDA 510(k)
FDA Class 1
·Physical Medicine
RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL
FDA 510(k)
FDA Class 2
·Radiology
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Rapid Aid Instant Disposable Infant Heel Warmer
FDA 510(k)
FDA Class 1
·Physical Medicine
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
HEARING AID TEST SYSTEM MODEL HAT 1000
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.
FDA Enforcement
Class II
·Terminated·Bomimed·October 11, 2017
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.
FDA Enforcement
Class II
·Terminated·Intellijoint Surgical, Inc.·April 1, 2020
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
FDA Enforcement
Class II
·Terminated·Abbott Point of Care Canada Limited·January 30, 2013
NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017
NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017
NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017