BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    FIBEROPTIC LASER DELIVERY SYSTEM

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

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139249150·UNITY KNEE™ PS-C INSERT - Size 8 x 10mm

    ArgenPMMA 98x12-CLR

    FDA UDI
    ARGEN CORPORATION, THE·D818120810·Crown And Bridge, Temporary, Resin

    Ophthalmic Conformer

    FDA UDI
    Midwest Eye Laboratories Woodbury, LLC·G290V2628·

    WeightRight®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020708·Tungsten-Filled Maloney Bougie Mini-Set

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981216856·Trial, 39mm x 27mm x 08mm, 10 Deg

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981214951·Interbody, 39mm x 27mm x 08mm, 10 Deg

    ELECSYS C-PEPTIDE CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442

    FDA 510(k)
    FDA Class 2 ·Hematology

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·January 15, 2013

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·December 16, 2012

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 20, 2013

    SYNCHRON URIC ACID

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code KNK·June 10, 2011

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 15, 2008

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·September 27, 2013

    BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 30, 2022

    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 GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018