BEUDAMED
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    VIDAS TESTOSTERONE (TES), MODEL 30 418

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NA

    FDA UDI
    STERILMED, INC.·10888551018517·BUR CARBIDE ROUND 8 FLUTES

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854004357·ULTRAPOWER BUR, ROUND (LIME) (COPPER), 3 MM

    NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD INTIMA II¿ IV CATHETER 24G X 0.75 IN.

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·November 2, 2017

    ENDO GIA ULTRA UNIVERSAL

    FDA Adverse Event
    Malfunction ·COVIDIEN ,FORMERLY VALLEY LAB, A DIVISION OF TYCO HEALTH CARE·Product code GDW·March 20, 2013

    35 CM BIPOLAR LEAD

    FDA Adverse Event
    Malfunction ·GREATBATCH MED·Product code DTB·February 8, 2011

    SELF CENT HIP 50X28 BRN

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·March 28, 2008

    OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014