BEUDAMED
    23 results · 25ms · Sources: EU EUDAMED, US FDA

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    OSCOR PERMANENT PACING LEAD RZ MODEL SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003888·S LEGACY Mic fcp, RH, NS DG, str 1.0 mm DD pft,...

    ImmunoDOT Serum Control D

    FDA UDI
    GenBio·00613745039183·Substitute Serum Control D for specimen. Otherw...

    KSEA PERCUTANEOUS FORAMINOSCOPY SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SECURE FLOW

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

    UCSS SCREW SET

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MRW·June 4, 2009

    UCSS SCREW SET

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code HWC·June 4, 2009

    UCSS

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2016

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 14, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 1, 2011

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·February 29, 2008

    UCSS SCREW SET

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·January 3, 2011

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 22, 2014

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 17, 2014

    UCSS SCREW SET

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 23, 2020

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 8, 2021

    GUIDE, SURGICAL, INSTRUMENT

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code FZX·September 25, 2019

    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