BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Surcam Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550162·GENUMEDI PT KNEE SUP SILVER L EW VII

    Symmetry Weitlaner

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482045220·Symmetry® Retractor, Weitlaner, Blunt, 3x4 Pron...

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517085839·

    Reliance Interspinous Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLOWMEDIC, MODEL 220

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523156849·Tesera-k ALIF, 42W X 32D, 17mm, 17° Trial

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523157594·Tesera-k ALIF, 42W X 32D, 17mm, 17° Broach

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523152261·Tesera-k SA, 42mm X 32mm X 17mm, 17° Lordosis, T3

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·August 18, 2021

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 11, 2023

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 11, 2022

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2023

    COOLFLEX E9000 HIGH SPEED DRILL

    FDA Adverse Event
    Injury ·CONMED LINVATEC·Product code HTW·November 19, 2008

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 9, 2011

    ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code OVE·July 23, 2013

    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