BEUDAMED
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    LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743649·ACHIMED ACHILLES SUPP SILVER I

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717102707·Air Water Syringe Tips Assorted Colors (250) - ...

    Kinesia 360

    FDA UDI
    Great Lakes Neurotechnologies Inc.·00859584006263·Kinesia 360 Tablet

    2.4MM CORTEX SCREW, SELF-TAPPING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HARDYDISK, SULFA/TRIMETH

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Kinesia 360

    FDA UDI
    Great Lakes Neurotechnologies Inc.·00859584006065·Kinesia 360, Tablet Assembly, Samsung Galaxy

    BD ALARIS¿ GP SERIES ONCOLOGY LIGHT-RESISTANT PRIMARY SET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·May 24, 2023

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD .·Product code MCM·March 25, 2013

    LEAD MODEL UNKNOWN

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·March 11, 2011

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·March 25, 2008

    UNKNOWN HUMERAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·July 9, 2021

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·July 19, 2022

    Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured by TOSOH CORPORATION, TOKYO, JAPAN

    FDA Recall
    Terminated ·Tosoh Bioscience, Inc.·Product code NIG·September 23, 2004

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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

    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