BEUDAMED
    240 results · 28ms · Sources: EU EUDAMED, US FDA

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    Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·July 15, 2015

    AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 12, 2025

    SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 2024

    SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 2024

    SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 2024

    SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 2024

    Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·February 19, 2025

    Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 2024

    MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·October 16, 2024

    CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·June 19, 2024

    AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·July 17, 2024

    TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·August 14, 2024

    CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821745

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·June 19, 2024

    CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see C2600P or C2600SRL on labeling. This notice is applicable for those SKUs as well

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·July 3, 2024

    Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

    CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·June 19, 2024

    Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

    Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

    Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·May 29, 2024

    Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024