BEUDAMED
    50 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    Non-sterile drape

    FDA Enforcement
    Class III ·Terminated·Novadaq Technologies, Inc.·December 3, 2014

    RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories, Limited·November 20, 2019

    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.

    FDA Enforcement
    Class III ·Terminated·Coloplast Manufacturing US, LLC·November 5, 2014

    DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

    FDA Enforcement
    Class III ·Terminated·DeRoyal Industries Inc·March 1, 2017

    SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

    FDA Enforcement
    Class III ·Terminated·DeRoyal Industries Inc·March 1, 2017

    STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

    FDA Enforcement
    Class III ·Terminated·Keystone Dental Inc·April 4, 2018

    LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

    FDA Enforcement
    Class III ·Terminated·Arc Medical Inc·May 20, 2015

    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

    FDA Enforcement
    Class III ·Terminated·Angiodynamics, Inc.·December 28, 2016

    LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.

    FDA Enforcement
    Class III ·Terminated·CooperVision Inc.·March 7, 2018

    CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.

    FDA Enforcement
    Class III ·Terminated·Sorin Group USA, Inc.·March 2, 2016

    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·July 27, 2022

    smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD Inc.·October 10, 2018

    L15-7IO TRANSDUCER Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025

    Transducer C10-3v Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025

    The UNI-CP System; Model Number: 330230SND.

    FDA Enforcement
    Class III ·Terminated·Integra LifeSciences Corp.·March 15, 2017

    OMNI II TEE Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025

    LUNA Chest, Model No. LU4006

    FDA Enforcement
    Class III ·Terminated·Novadaq Technologies, Inc.·December 3, 2014