BEUDAMED
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    B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPANION MODEL 221, 321, 421

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ULTRAGUIDE CT-GUIDE 1010

    FDA 510(k)
    FDA Class 2 ·Radiology

    HELICAL BLADE INSERTER

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code LXH·March 26, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011

    MICROSTAAR FOAM TIP PLUNGER

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code MSS·March 26, 2008

    FARADRIVE STEERABLE SHEATH CLEAR

    FDA Adverse Event
    Malfunction ·FARAPULSE, INC.·Product code DRA·December 8, 2025

    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

    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