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

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    MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SampLok® Adapter Cap 3 Insert

    FDA UDI
    ITL ASIA PACIFIC SDN. BHD.·09555240401557·SampLok® Adaptor Cap 3 (SAC 3) Insert is an opt...

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494464195·Blakesley Biopsy Grasping Forceps D 5.0mm, WL 1...

    PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    GOODNET

    FDA 510(k)
    FDA Class 2 ·Radiology

    LUMAX 540 DR-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·May 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011

    SUBDURAL CATHETER KIT COMPLETE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code JXG·March 20, 2008

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    TherMax Blood Warmer Unit

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

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    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

    VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025