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

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    HYPERGEL 20% HYPERTONIC SALINE GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984370·anteriors; shade B4; mould Q 62

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707035525·.017 X .025 Lower Elastinol™ Natural Form Archw...

    GENESIS III, (MOD. 7003/7004)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CMS IV EXTENSION SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OSS AXLE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 1, 2016

    OSS REINFORCED YOKE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KRO·September 1, 2016

    OSS NON-MOD TIB PLATE LONG 75

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KRO·September 1, 2016

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 10, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 6, 2014

    Vanguard XP Tibial Tray 69 mm Item # 195248

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    OSS 7CM SEG ELLIPT FEMORAL LT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·June 28, 2016

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

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