BEUDAMED
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    MAVIDON MEDICAL ELECTRODE JELLY

    FDA 510(k)
    FDA Class 2 ·Neurology

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003901·S LEGACY Mic fcp, RH, NS DG, str 1.0 mm DD pfrt...

    FALOPE RING BAND

    FDA Adverse Event
    Malfunction ·CABOT MEDICAL PRODUCTS·Product code HFY·November 7, 1994

    3D ENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    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

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MAF·November 20, 2006

    UCSS

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

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 14, 2013

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·March 1, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 12, 2014

    UCSS SCREW SET

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

    UCSS SCREW SET

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

    GUIDE, SURGICAL, INSTRUMENT

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

    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

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 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

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

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