BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    MALE LATEX CONDOM

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

    OPTIMUS

    FDA UDI
    SPINAL ELEMENTS·00840916129293·Optimus PEEK End Cap 29 x 36, 7deg - A

    Sensor

    FDA UDI
    Respironics, Inc.·00606959050822·External Flow Sensor w/Cable, Pediatric / Infant

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053494·PEERLESS 2NDMOL 6DEG LR WDX-32TX022

    NexxZr™ T / D-100-25-NT-C100-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113177·

    RAVINE Lateral Access System

    FDA UDI
    VB Spine LLC·10888857560949·A/P Lateral Access Blade Size 13x130 mm

    BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSSTAPLE CHILL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    FDA Adverse Event
    Other ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 16, 2011

    SORIN HEATER-COOLER SYSTEM 3T

    FDA Adverse Event
    Death ·SORIN GROUP DEUTSCHLAND·Product code DWC·November 22, 2016

    Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014