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    RADIALIS INC.

    FDA registration
    RADIALIS INC.·1 product·🇨🇦 Canada

    RADIALIS PET IMAGER

    FDA UDI
    Radialis Inc·00850031455337·The Radialis PET Imager (or Radialis PET Camera...

    RADIALIS PET CAMERA

    FDA UDI
    Radialis Inc·08500314551332·The Radialis PET Camera (or Radialis PET Imager...

    RADIALIS PET CAMERA

    FDA UDI
    Radialis Inc·00850031455016·The Radialis PET Camera (or Radialis PET Imager...

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 24, 2025

    DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code MBI·May 25, 2024

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·August 22, 2024

    ETHLN BLK 6IN 9-0 S/A BV100-4

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAR·December 1, 2023

    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·April 19, 2017

    Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·February 5, 2014

    e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·May 15, 2012

    BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·April 8, 2020

    Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging, whole-body scans, and SPECT studies.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·May 15, 2012

    D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Radial hemostatic band (D-Stat Radial) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Application device consisting of an adjustable retention strap, collar and attached gauze pad.

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code FRO·September 9, 2005

    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DXC·March 3, 2017

    QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF. Radial artery catheterization kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·October 29, 2010

    e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·February 10, 2003

    e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS--·September 5, 2003

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Recall
    Terminated ·Cook Inc.·Product code DYB·February 1, 2017

    BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code PQK·April 12, 2019