BEUDAMED
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    Dental Zirconia Blocks

    FDA 510(k)
    FDA Class 2 ·Dental

    Edge™ Diamond FP016-4F (3.5) Football Pointed

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003322·Diamond dental bur, reusable

    ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REFLEX BALLON GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY RIGHT ANGLE 5 MM

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code OWN·March 5, 2025

    ACCENT SR RF OUS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    M2A 38MMX54MM CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013

    ACCU-CHEK ® INFORM II TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 30, 2015

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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