BEUDAMED
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    VENODYNE DVT ADVANTAGE PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036008727·

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0113100·Decorticating Planer

    CPAP SYSTEM, MODEL 102001

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRIMA OXYGEN MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 17, 2021

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 4, 2024

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 14, 2018

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·February 6, 1998

    TEMPBOND CLEAR WITH TRICLOSAN

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·March 19, 2013

    UNKNOWN DEPUY FEMORAL SLEEVE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·March 4, 2011

    STARCLOSE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·March 11, 2008

    BD PHASEAL OPTIMA CONNECTOR (C35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·May 26, 2021

    Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.

    FDA Recall
    Terminated ·Product code HRY·April 22, 2011

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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