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

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    TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780145912·Integra® Jarit® C-T-V Bottom Cap, For REF#'s 60...

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00530361·

    Mariner MCT

    FDA UDI
    Seaspine Orthopedics Corporation·10889981170165·3.5mm Drill, Solid, A/O QC

    Mariner MCT

    FDA UDI
    Seaspine Orthopedics Corporation·10889987170169·3.5mm Drill, Solid, A/O QC

    ENTEC REFLEX WAND 55, MODEL E4055-00

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

    FDA 510(k)
    FDA Class 2 ·Immunology

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 17, 2021

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 17, 2021

    2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HTO·March 13, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·February 8, 2011

    ACTIVA

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

    AUTOCOMP6 XPS High Speed Compounder REF 58810

    FDA Enforcement
    Class II ·Terminated·The Metrix Company·August 3, 2016

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015

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

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