BEUDAMED
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    STAT K IN VITRO DIAGNOSTIC TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    25GA Illuminating Laser Probe, SMA905

    FDA UDI
    Peregrine Surgical, Llc·00632307002120·25GA Illuminating Laser Probe, SMA905

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871500·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

    MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 9, 2013

    ENDO GIA ROTICULATOR 60-3.5 SULU

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·March 29, 2011

    VITALITY 2 VR EL

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 23, 2025

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013