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

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    MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019

    FDA 510(k)
    FDA Class 2 ·Neurology

    AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 135mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665021158·

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70611351·Mini Sprint-Brackets .022" Easytwin class III 2...

    6F & 7F INTRODUCING CATHETERS (MODIFICATION)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GSI AUDERA

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 10, 2025

    1.0MM TI CRTX SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·April 16, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 18, 2011

    MODEL 90478 TELEMETRY RECEIVER MODULE

    FDA Adverse Event
    Other ·SPACELABS HEALTHCARE·Product code MHX·June 13, 2008

    Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·May 31, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015