BEUDAMED
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    DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Safco SafeWrap Chair Sleeves

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063751972·Safco SafeWrap full chair sleeve, 29" x 80", 12...

    Ligatures

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746156298·LIGATURE 20 STICK BLACK 50/BAG

    Ligatures

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746077487·LIGATURE 20 STICK BLACK 50/BAG

    HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    BNF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 27, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 17, 2011

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·March 28, 2008

    BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·November 12, 2018

    ASAHI PROWATER

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

    ASAHI PROWATER

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

    CAP FOR INJECTOR MEMBRANE M50

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·May 4, 2021

    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