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

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    Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

    FDA 510(k)
    FDA Class 2 ·Immunology

    Fog-Free Photo Mirrors Replacement Pack

    FDA UDI
    PRACTICON, INC.·00723896023761·Practicon Fog-Free Mirrors Replacement Pack fea...

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154020669·Cruciate Retaining Tibial Insert

    KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS

    FDA 510(k)
    FDA Class 2 ·Neurology

    INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Coaxial SABD Biopsy Device

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333218165·Coaxial SABD Biopsy Device

    Single Action Biopsy Device

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333218646·Single Action Biopsy Device 16g (1.7mm) x 9cm

    CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 1, 2020

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·June 16, 2011

    INTRA-AORTIC BALLOON CATHETER 8FR 40CC

    FDA Adverse Event
    Malfunction ·DATASCOPE, INC.·Product code DSP·September 12, 2008

    WAVEWRITER ALPHA? 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 20, 2025

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·August 12, 2025

    Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 4, 2018

    Artis zeego, Model Number 10280959

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

    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen 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 AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017

    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 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.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018