BEUDAMED
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    FEMOSTOP FEMORAL COMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APC™ PLUS Victory Series™ Low Profile

    FDA UDI
    3M UNITEK CORPORATION·00652221094711·Victory Series(TM) Low Profile Bracket APC(TM) ...

    APC™ Flash-Free Victory Series™ Low Profile

    FDA UDI
    3M UNITEK CORPORATION·00652221232304·Victory Series(TM) Low Profile Bracket APC(TM) ...

    3M™ Unitek™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221017888·Victory Series(TM) Low Profile Bracket Roth U/L...

    ENDIUS CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMARTEPIL

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

    NavaClick Syringe and Needle, Model Number LIN02

    FDA Enforcement
    Class III ·Ongoing·LINEAGE BIOMEDICAL, INC·August 14, 2024

    NAIL DISP PINS, DRIL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code LXH·March 27, 2013

    CENTURY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 11, 2011

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·April 5, 2008

    ARCHITECT C4000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 1, 2024

    SINGLE USE ELECTROSURGICAL KNIFE

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code KNS·February 24, 2026

    SINGLE USE ELECTROSURGICAL KNIFE

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code KNS·February 24, 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