BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    Modified Novy Cornual Cannulation Set

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODIFIED NOVY CORNUAL CANNULATION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MOV·March 14, 2024

    MODIFIED NOVY CORNUAL CANNULATION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MOV·January 10, 2024

    MODIFIED NOVY CORNUAL CANNULATION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MOV·November 22, 2024

    Comprehensive® Reverse Shoulder

    FDA UDI
    Biomet Orthopedics, LLC·00880304677159·

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189552821·IN-OVATION® R EURO 022 UL/5-5 CS-BC HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189552811·IN-OVATION® R EURO 022 UL/5-5 CS HK

    CYTO-CHEX BCT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RAYSTATION VERSION 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·September 13, 2011

    SYMBIQ 3.13 DUAL CHA

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 15, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    SOL 2.25X15.0 CALCAR 9.0 R

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 20, 2013

    COMPR SRS MOD STEM - 16X75MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·January 31, 2018

    Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·December 23, 2020

    Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·November 25, 2020