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

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    ADVANTA SST GRAFT (<6MM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964150722·Endo Carry-on Procedure Kit contains Intercept ...

    D-SPECT Refurbished

    FDA UDI
    SPECTRUM DYNAMICS MEDICAL, INC·07290108670097·The D-SPECT® system is a single photon emission...

    D-SPECT Refurbished

    FDA UDI
    SPECTRUM DYNAMICS MEDICAL, INC·07290108670523·Single Photon Emission Computed Tomography system

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm

    LIFE SCOPE EC, MODEL BSM-1102

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 14, 2013

    UNKNOWN ZIMMER TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 1, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code LWS·February 7, 2008

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023

    Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units 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 analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019