BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521309140·

    TALOS®-C

    FDA UDI
    SpineArt SA·07640375236555·STERILE TALOS®-C (HA) PEEK PLANAR IBFD

    TRIPLE LUMEN PFM PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REBILDA DC

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·May 24, 2013

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011

    BABYLOG 8000

    FDA Adverse Event
    Injury ·DRAEGER MEDICAL AG & CO. KG·Product code CBK·August 7, 2008

    BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE XL +7

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 14, 2021

    G7 HI-WALL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·May 23, 2018

    G7 ARCOMXL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·May 23, 2018

    G7 ACETABULAR 3 HOLE SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·May 23, 2018

    G7 ACETABULAR 3 HOLE SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·May 23, 2018

    ALARIS 10 INCH EXT W/ 0.2 PED & VLV PORT

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·November 19, 2019

    Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 14, 2016

    K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015