BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET

    FDA 510(k)
    FDA Class 2 ·Hematology

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780145875·VALVE SPRING FOR 600-430

    CorticaLINK

    FDA UDI
    LINKSPINE, INC.·00817329020103·5.0mm Titanium Rod: 30mm Straight

    FacetFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361019909·Facet Screw Assy, SOTW, 4.5 x 30mm

    SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    System M ®

    FDA UDI
    SPECTRUM MEDICAL LIMITED·05060434420183·Low Flow - (0.5 - 3.0 L/min)

    System M ®

    FDA UDI
    SPECTRUM MEDICAL LIMITED·05060434420176·Ultra Low Flow - (0.05 - 0.5 L/min)

    System M ®

    FDA UDI
    SPECTRUM MEDICAL LIMITED·05060434420145·Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Lo...

    System M ®

    FDA UDI
    SPECTRUM MEDICAL LIMITED·05060434420152·Low Flow - (0.5 - 3.0 L/min) - Low Flow Gas Mo...

    System M ®

    FDA UDI
    SPECTRUM MEDICAL LIMITED·05060434420169·High Flow - (1.0 - 7.0 L/min) - High Flow Gas ...

    System M ®

    FDA UDI
    SPECTRUM MEDICAL LIMITED·05060434420190·High Flow - (1.0 - 7.0 L/min)

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·March 13, 2013

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 28, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·February 11, 2008

    Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" REF 003030, 20F, Sterile.

    FDA Recall
    Terminated ·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008

    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

    Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 12, 2018

    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