BEUDAMED
    42 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code ODG·May 23, 2017

    Trident Endoscopic Ultrasonic Biopsy Needle (FNB)

    FDA Recall
    Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code ODG·March 12, 2018

    Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·October 16, 2020

    Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

    FDA Recall
    Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code ODG·March 12, 2018

    Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·October 16, 2020

    Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·October 16, 2020

    Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code ODG·April 6, 2016

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code ODG·May 23, 2017

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·August 21, 2015

    Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·October 16, 2020

    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HRS·September 3, 2021

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    ADJUSTABLE DRILL GUIDE, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    7.2cm Adjustable Drill Guide Product Usage: Electric system

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 13, 2021

    TopCare Clifford THE BIG RED DOG power toothbrush for kids!

    FDA Recall
    Terminated ·Ranir Corporation·Product code JEQ·December 18, 2013

    TopCare Clifford THE BIG RED DOG power toothbrush for kids!

    FDA Enforcement
    Class II ·Terminated·Ranir Corporation·January 29, 2014

    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium

    FDA Recall
    Terminated ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018

    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium

    FDA Recall
    Terminated ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018

    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium

    FDA Recall
    Terminated ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code GWO·June 22, 2018