BEUDAMED
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    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code DRF·June 5, 2019

    RESONANT LIGHT, INC. OF B.C., CANADA

    FDA Adverse Event
    Other ·RESONANT LIGHT TECHNOLOGY INC.·Product code LDQ·October 25, 2002

    ON-X PROSTHETIC VALVE UNKNOWN CONFIGURATION

    FDA Adverse Event
    Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·November 1, 2024

    REBUILDER

    FDA Adverse Event
    Injury ·REBUILDER MEDICAL, INC.·Product code GZJ·June 1, 2022

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B.BRAUN MELSUNGEN AG·Product code FRN·June 16, 2023

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·February 8, 2022

    ON-X PROSTHETIC HEART VALVE

    FDA Adverse Event
    Malfunction ·ON-X LIFE TECHNOLOGIES, INC·Product code DYE·April 27, 2016

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Blue Belt Technologies MN·August 28, 2013

    Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is intended for use Bone Marrow Biopsy.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008

    Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008

    Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008

    Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.

    FDA Enforcement
    Class II ·Terminated·PROVIDENCE MEDICAL TECHNOLOGIES·July 1, 2020

    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

    Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

    Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product Number: 500118200. 510k K944522. Qty Dist. - 4,180. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Prostate Stabilization Set

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code IWJ·September 1, 2009

    PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·April 2, 2009

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code KKX·July 19, 2013

    Angiotech Drainage Cather. SKATER Centesis Cather XFr. STERILE. Product Number: 700304007, 700304010, 700304015, 700305007, 700305010, 7003015. 510k Exempt. Qty Dist. - 4,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Drainage Cather

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code JCY·September 1, 2009

    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

    Angiotech Needle Guide. Needle Guide for Lorad Stereo Loc. STERILE. Product Number: LNGC14GX, LNGC1619PX, LNGC2022YX, LNGO1619PX, LNGO2022YX. 510k Exempt. Qty Dist. - 13,800. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Needle Guide

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code GDF·September 1, 2009