BEUDAMED
    31 results · 22ms · Sources: EU EUDAMED, US FDA

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    VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019

    HEMOPRO 2 ADAPTOR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 21, 2020

    Preci-Clix

    FDA UDI
    Preat Corporation·00842092127223·Universal Threaded Ball 2.2mm

    Needle Guide

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102961·Sterile endocavity needle guide with (2.0 x 20c...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450160183·

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

    MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018

    ATLAS II DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    PRECISION XTRA

    FDA Adverse Event
    Injury ·Product code NBW·May 24, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·November 1, 2023

    Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·May 10, 2023

    Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·June 13, 2018