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    MITEK BIOCRYL INTERFERENCE SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GC Fuji ORTHO™

    FDA UDI
    Gc America Inc.·14548161331999·Ortho LC Paste Pak Automix Refill SL

    ACUFEX

    FDA UDI
    Smith & Nephew, Inc.·03596010091192·ACL CHAMFERING RASP 7 MM, HALF-ROUND

    GC Fuji ORTHO™

    FDA UDI
    Gc America Inc.·D0470135721·Ortho LC Paste Pak Automix Refill SL

    CONTACT DETACH

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 5, 2026

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508275·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508282·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508299·

    BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE

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

    DYONICS CONTROL RF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEE H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 20, 2013

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·March 10, 2011

    NONE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 10, 2008

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·May 23, 2016

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015