BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    RIGID GAS PERMEABLE CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TECOFLEX

    FDA UDI
    Gyrus ACMI, LLC·00821925005112·6.0FR(2mm) X 22-28 cm QUADRA-COIL URETERAL STEN...

    Thuvera

    FDA UDI
    IPG Medical Corporation·00810071230141·Thuvera Wireless Footswitch

    LIFEPAK® 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873871669·15AABBABBBBBBAAAAAAAAAAFLP15 MONITOR/DEFIB

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·February 20, 2015

    VERSABOND BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900

    FDA 510(k)
    FDA Class 2 ·Radiology

    AP STANDARD RAPID-PORT EZ

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·March 11, 2013

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 27, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 12, 2014

    LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·September 29, 2023

    LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·November 22, 2023

    LOCKING SCREW, T7 DIAM.2.3X18MM

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code HRS·October 7, 2017

    LIGHT ADJUSTABLE LENS (LAL)

    FDA Adverse Event
    Injury ·RXSIGHT, INC.·Product code PZK·July 27, 2021

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·March 18, 2020

    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

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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