BEUDAMED
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    Concerto Versa, Detachable Coil

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Advanced Instruments Swab Cleaners

    FDA UDI
    Advanced Instruments, LLC·00816068020658·Advanced Instruments swab cleaners are used to ...

    NA

    FDA UDI
    Synthes GmbH·10886982144928·2.7MM CORTEX SCREW SELF-TAPPING 50MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112861·CORNEAL TREPHINE BLADE6.0MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112458·BARRON VACUUM TREPHINE 6.0MM

    MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Fujifilm Ultrasonic Processor

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

    COCR HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·March 12, 2018

    SPIN SCREW DIAM. 2MM LG 14MM

    FDA Adverse Event
    Other ·NEWDEAL S.A.·Product code HWC·October 16, 2008

    SENSIA SR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·November 26, 2025

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·July 22, 2025

    ALINITY I HAVAB-IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

    ALINITY I HAVAB-IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·January 23, 2026

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·January 16, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    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