BEUDAMED
    20 results · 28ms · Sources: EU EUDAMED, US FDA

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    NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310212313·FG Diamond 835-012 cylinder flat end fine (gold...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780798·LEVAMED ACTIVE ANKLE SUP SLVR R I

    NA

    FDA UDI
    STERILMED, INC.·10888551018470·BUR CARBIDE ROUND 10 FLUTES

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854004777·ULTRAPOWER BUR, ROUND (MUSTARD) 7.5 MM

    CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN

    FDA 510(k)
    FDA Class 1 ·General Hospital

    THE KALIX IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 22, 2014

    TAPERLOC MICROP FMRL 7.5MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 13, 2022

    PFC*SIGMA/RD/DOME PAT 3PEG,35

    FDA Adverse Event
    Injury ·DEPUY IRELAND ? REG. # 9616671·Product code JWH·March 26, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 28, 2008

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICALE CIE INC·Product code DXF·April 15, 2025

    SELEX/MAGNUM MOD HD 40MM -3

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·September 14, 2022

    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·February 4, 2015

    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

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014