BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131256676·NERA PRO, BTE 13 WL 100 CBE DEMO

    NexxZr™ T / D-100-25-NT-A350-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112514·

    ihcDirect® TTF1 Ab, 15mL

    FDA UDI
    NOVODIAX, INC.·00850000596658·Clone R373

    ihcDirect® TTF1 Ab, 5mL

    FDA UDI
    NOVODIAX, INC.·00850000596641·Clone R373

    ihcDirect® TTF1 Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934703·Clone R373

    ihcDirect® TTF1 Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934697·Clone R373

    DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIXPLORER

    FDA 510(k)
    FDA Class 2 ·Radiology

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 16, 2011

    MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34

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

    MPACT ACETABULAR SHELL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LPH·July 9, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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