BEUDAMED
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    pHoenix ISE Reagents FOR Olympus AU Chemistry Systems

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101878·Burs FG 6, Pkg/100

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037314326·K-WIRE CENTER GUIDE Ø48 mm

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036019358·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157497·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157732·

    NA

    FDA UDI
    STRYKER CORPORATION·04546540756169·5MM FEMORAL REAMER 3-FLUTED

    RGP MULTI-PURPOSE SOLUTION ID 100136

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ELECSYS HCG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Logical G-Series Cup Shell - Multi Hole

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215094539·

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·March 25, 2013

    2.5MM DRILL BIT/QC/GOLD/110MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWE·March 7, 2011

    Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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