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

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    VIVA EB

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1203340·

    INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC

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

    DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QJR·September 21, 2021

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    G7 PPS LTD ACET SHELL 52E

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·January 30, 2023

    G7 CURVED INSERTER THD SHAFT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·January 4, 2023

    G7 CURVED INSERTER THD SHAFT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·January 4, 2023

    KENTROX SL-S 65/16 STEROID

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·May 20, 2013

    ERYTYPE S RH-PHENO DOUBLE

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·September 26, 2014

    FORCETRIAD

    FDA Adverse Event
    COVIDIEN VALLEYLAB·Product code GEI·May 27, 2011

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024