BEUDAMED
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    MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Symmetry Metzenbaum

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482038437·Symmetry® Scissors, Metzenbaum, Curved, Standar...

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962113349·METZENBAUM SCISSORS, 7 1/8", CVD, W/MICRO SERRA...

    ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

    FDA 510(k)
    FDA Class 2 ·Hematology

    PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X

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

    SYRINGE CATHETER TIP 50ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code KYZ·August 27, 2025

    EPD 60000 RPM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·April 9, 2013

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 25, 2011

    DISCOVERY II DR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

    DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZI·September 3, 2013

    CABLE 3M TO CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014

    FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Injury ·COOK INC·Product code EZN·May 21, 2019

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018