BEUDAMED
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    Ora Medical Inc.

    Manufacturer
    🇨🇦 Canada·2 Importers

    ORA MEDICAL INC

    FDA registration
    ORA MEDICAL INC·1 product·🇨🇦 Canada

    Levity

    FDA UDI
    Ora Médical Inc·00628719745014·HealthCare Professional Kit

    Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego¿ is a needle-free capping device which closes the end of the catheter. The Tego¿ will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 18, 2017

    SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

    FDA Enforcement
    Class II ·Terminated·ASI Medical, Inc.·December 25, 2013

    Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Austria. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part number 88004051, Nautica Bath Lift System; b) Distributed by Whitehall Manufacturing, P.O. Box 3527, City of Industry, CA 91744, Manufactured by BHM Medical Inc., Canada: Part number 88004051.12, Nautica Bath Lift System

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·January 23, 2007

    BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of the following patient lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift; Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift; b) Manufactured for Sunrise Medical, Longmont, CO 80503: Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FRW·December 19, 2007

    BALLARD CLOSED SUCTION SYSTEM, ADULTS,14 FR,DSE,MDI

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BSY·March 31, 2023

    GUIDESTAR STEERABLE GUIDING SHEATH

    FDA Adverse Event
    Death ·OSCOR INC.·Product code DYB·November 22, 2024

    MIC JEJUNOSTOMY FEEDING TUBE - 14 FR

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KNT·May 18, 2023

    RIATA ACTIVE-FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 11, 2006

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·April 25, 2024

    microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" Drive System, Product Number MT-DS-01

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD-01

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006

    FDA Recall
    Terminated ·FHC, Inc.·Product code HAW·May 10, 2018