BEUDAMED
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    ELECSYS CA 125 II CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169328327·TEMPLATE 3003969 ZEVO 69MM 3 LVL

    LINK Instruments - Rasps, compressors and broaches

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575293438·Orthopaedic prosthesis instrument, reusable - G...

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·December 23, 2024

    MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 14, 2013

    SOFTCLIX® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 1, 2011

    TC3 RP TIBIAL INSERT S5, 10.0

    FDA Adverse Event
    Injury ·DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·February 22, 2008

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 8, 2025

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 8, 2025

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 8, 2025

    Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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

    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

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

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