BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    Healing Abutment, Cover Screw

    FDA 510(k)
    FDA Class 2 ·Dental

    GRYPHON

    FDA UDI
    DEPUY MITEK, LLC·10886705024131·GRYPHON Slotted Fishmouth Guide

    MARA PROBE

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code MNB·April 18, 2022

    MARA PROBE

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code MNB·October 10, 2022

    SOLUTION SYSTEM

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295087021·SOLUTION SYSTEM THINSHAFT REAMER 13.5mm DIA

    CUROS PORT PROTECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 21, 2023

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021

    RED CELL LYSING REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GGK·August 12, 2011

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·August 1, 2014

    LIBERTY CYCLER

    FDA Adverse Event
    Other ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·July 2, 2013

    GRYPHON SLOTTED FISHMOUTH GUIDE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code LXH·July 6, 2023

    GRYPHON SLOTTED FISHMOUTH GDE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code LXH·March 2, 2021

    Destino Twist 14F (also branded as Guidestar 14F)

    FDA Enforcement
    Class II ·Completed·Oscor Inc.·February 23, 2022

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018