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

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    QUANTA LITE RNA POL III ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ComfortGel Blue

    FDA UDI
    Respironics, Inc.·00606959001596·ComfortGel Blue Nasal Mask with Headgear, Small...

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690798·Titanium Base Abutment Internal Hex. SP H1mm En...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306802010·Kocher Hemostatic Forceps, Straight, 1x2 Teeth,...

    PERSONA® Persona SoluTion™

    FDA UDI
    Zimmer, Inc.·00889024231795·

    PERSONA® Persona SoluTion™

    FDA UDI
    Zimmer, Inc.·00889024231801·

    VERCISE PC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·January 3, 2022

    SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    5C-ES CELL CONTROL, MODELS 7547191, 7547192

    FDA 510(k)
    FDA Class 2 ·Hematology

    6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·April 22, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 26, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·July 3, 2008

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2015

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·September 22, 2016

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016