BEUDAMED
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    FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Signature

    FDA UDI
    SILEX MEDICAL, LLC·B33158640000·Atraumatic Grasper

    Signature

    FDA UDI
    SILEX MEDICAL, LLC·B331586400045·Long Locking Gall Bladder Grasping Forceps

    Sphere Introducer

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110836·CARTER SPHERE INTRODUCER

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964091247·The ENDO CARRY-ON Procedure Kit contains all of...

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971833·

    TANDEM VISUAL HCG IMMUNOENZYMETRIC

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RIONET HEARING AID HB-73

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    NA

    FDA UDI
    Zimmer, Inc.·00889024024403·

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.

    FDA Enforcement
    Class II ·Ongoing·Silex Medical, LLC·June 11, 2025

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 11, 2010

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 10, 2012

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 10, 2014

    Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.

    FDA Recall
    Open, Classified ·Silex Medical, LLC·Product code GEI·January 9, 2024

    ARCOS 19X190MM SPL TPR DIST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 14, 2018

    TI LOW PROFILE SCREW 6.5X50MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 13, 2018

    TI LOW PROFILE SCREW 6.5X50MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 13, 2018

    FREEDOM CONSTR. LINER +5 SZ 24

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWZ·March 13, 2018