BEUDAMED
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    INFINITY MCABLE - MAINSTREAM CO2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Bur PM2-70 80K Diamond coarse Ø4.0 sterile

    FDA UDI
    Bien-Air Surgery SA·17630055513981·

    Uni-Heart™ Lo-Flo Continuous Nebulizer, Pediatric Mask,7'

    FDA UDI
    WESTMED, INC.·00709078000300·Uni-Heart™ Lo-Flo Continuous Nebulizer, Pediatr...

    ARGELOY NP (kg)

    FDA UDI
    ARGEN CORPORATION, THE·D818100941·Base metal alloy

    BETA TITANIUM ARCHWIRE

    FDA UDI
    Ortho Organizers, Inc.·00190707067106·.016 Upper Pro Form™ Beta Titanium Archwires

    THE NIMBLE ROCKET POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STERLTECH WATER PURIFIER

    FDA 510(k)
    FDA Class 1 ·Dental

    BD ORAL SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code KYW·January 26, 2026

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code NIQ·May 5, 2020

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·September 19, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2011

    TASUKI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·June 6, 2019

    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015