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

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    FLAT PANEL DETECTOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    AF541

    FDA UDI
    Respironics, Inc.·00606959024731·AF541 Discharge Kit, Capstrap Large / Extra Large

    HemoCue® Glucose 201 DM Analyzer

    FDA UDI
    Hemocue AB·07311091214447·HemoCue Glucose 201 DM Analyzer mmol/L plasma

    MaxFuse VBR, 10 (D) x 12 (W) x 55 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055646·VBR, 10 (D) x 12 (W) x 55 (H)

    CYNOSURE PHOTOGENICA SV

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

    AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY

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

    Zavation

    FDA UDI
    Zavation LLC·00842166122796·Cage - 12x14mm, 44-76mm, 15°

    Zavation

    FDA UDI
    Zavation LLC·00842166122772·Cage - 12x14mm, 44-76mm, 5°

    Zavation

    FDA UDI
    Zavation LLC·00842166122765·Cage - 12x14mm, 44-76mm, 0°

    Zavation

    FDA UDI
    Zavation LLC·00842166122789·Cage - 12x14mm, 44-76mm, 10°

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 31, 2022

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929064788·Corpectomy, 12Dx14Wx44H 0°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929034798·Corpectomy, 12Dx14Wx44H 6°

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    TA 45-3.5 SINGLE USE RELOADABLE STAPLER

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·June 7, 2011

    DST SERIES EEA ORVIL 25MM DEVICE

    FDA Adverse Event
    NORTH HAVEN - USS·Product code GDW·August 13, 2008

    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Artis Q biplane, Model Number 10848282

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018