BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    PHOSPHORUS REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Autosoft XC

    FDA UDI
    Unomedical A/S·05705244021099·Single use infusion set for subcutaneous infusi...

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003857·S LEGACY Mic fcp, RH, NS DG, str 1.0 mm DD pft,...

    ImmunoDOT Thyroid Positive Control

    FDA UDI
    GenBio·00613745039121·Thyroid Positive Control contains antibodies sp...

    SECURE FLOW

    FDA Adverse Event
    Injury ·WOO YOUNG MEDICAL INC.·Product code MEB·March 27, 2012

    VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073

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

    IM-9B MICROINJECTORS

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

    ELEVATOR #301

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code EMJ·June 19, 2017

    DERMABOND ADVANCED

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code MPN·March 14, 2013

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL,INC.·Product code NAY·March 1, 2011

    OEC 9800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code JAA·January 28, 2008

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·September 26, 2012

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

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

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