BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964020221·Endo Carry-On Procedure Kit

    TruSteel™

    FDA UDI
    Unomedical A/S·05705244018518·Single use infusion set for subcutaneous infusi...

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·September 4, 2024

    MINMED QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 8, 2024

    BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 13, 2025

    PRIME BIG WHEEL STRETCHER,30"

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 13, 2013

    BALANCED SALT SOLUTION

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code KIP·February 28, 2011

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Other ·STAAR SURGICAL·Product code HQL·February 26, 2008

    PUMP 381 PUMP SET (US)

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·February 5, 2026

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Enforcement
    Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 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

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024