BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    LIQUICHEK TDM CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    CRIT-LINE MONITOR III TQA (CLM TQA)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·March 20, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2011

    BIORAPTOR 2.9 SUTURE ANCHOR W/TWO SUTURES

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code MBI·March 12, 2008

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·June 23, 2023

    PLASTIPAK LUER-LOK

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 16, 2025

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR CLONMEL·Product code NIQ·September 3, 2010

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR CLONMEL·Product code NIQ·September 3, 2010

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·September 3, 2010

    The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·May 2, 2018

    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

    Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product 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.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 3, 2019

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024