BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Enamelite

    FDA UDI
    Keystone Industries·H66851001861·AEROpaque Spray Opaque Shade A4 Medium

    EVEREST & JENNINGS

    FDA UDI
    GF HEALTH PRODUCTS, INC.·M36881001861·COMFORT CUSHION 18X16X3

    Debakey Adson Tissue Forceps

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896122345·Debakey Adson Tissue Forceps Tungsten Carbide 1...

    Scanlan® TIP-GUARD™ instrument protectors - Colored

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159002256·Scanlan® TIP-GUARD™ instrument protectors - Gre...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319701881·Metzenbaum Dissecting Scissors 9" (22.5cm), str...

    DATEX-OHMEDA INOVENT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVERA MRI XT DR SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LWS·September 3, 2025

    AFFINITY THREE BIRTHING BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·April 29, 2013

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 18, 2014

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 24, 2011

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    UNIVERSAL CHUCK WITH T-HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES RARON·Product code LXH·February 15, 2017

    STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP

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

    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·March 22, 2017

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    FDA Enforcement
    Class II ·Terminated·CSA Medical·January 14, 2015

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020