BEUDAMED
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    E.COLI/P. AERUGINOSA PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NA

    FDA UDI
    STERILMED, INC.·10888551018319·BUR CARBIDE MICRO OVAL 8 FLUTES LONG

    CONMED

    FDA UDI
    Conmed Corporation·10845854001257·OVAL BUR, LONG, CARBIDE, 4 X 8 MM

    HORIZONS PAPILLOTOME

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STARS2000 POWER CANNULA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NEOCIF INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018

    NEOCIF INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017

    TPRLOC COCR CMTD STM T1 12.5MM

    FDA Adverse Event
    Death ·BIOMET UK LTD.·Product code JDI·March 23, 2026

    CMK MOD 12/14 SZ202 L130

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LZO·November 24, 2025

    PHILIPS INFORMATION CENTER

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·April 29, 2013

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·September 16, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 29, 2026

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWY·July 20, 2023

    CMK MOD 12/14 SZ202 L130

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·January 8, 2026

    Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    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