BEUDAMED
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    EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)

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

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973646·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973561·

    NA

    FDA UDI
    Synthes GmbH·10887587034898·1.5MM DRILL BIT/QC/85MM

    Procure

    FDA UDI
    Twin Med, LLC·10840330700778·Trach Tie Adult, w/moisture repellent material,...

    BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION

    FDA 510(k)
    FDA Class 2 ·Dental

    WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACUITY CENTRAL STATION

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code DSI·June 13, 2007

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·May 3, 2013

    CORMET RESURFACING

    FDA Adverse Event
    Injury ·CORIN LTD.·Product code NXT·August 27, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    VIPER

    FDA Adverse Event
    Malfunction ·DEPUY SPINE·Product code MNI·September 14, 2017

    TherMax Blood Warmer Unit

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

    Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    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

    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

    GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 11, 2018

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 19, 2019