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

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    STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS

    FDA 510(k)
    FDA Class 2 ·Dental

    Tru-Chrome

    FDA UDI
    Rmo, Inc.·00885797016812·TRU-CHROME NAT ARCH MX .016 X .022

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108698497·Straight Paltop Equator Abutment Conical H5mm

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215023331·

    Crescendo Meniscal Insert PS 15mm Size 1

    FDA UDI
    AMPLITUDE SAS·03701089525299·

    SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES

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

    ENT LASERVISION

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

    VERCISE GEVIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·June 27, 2023

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 22, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011

    *

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTD·July 10, 2008

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    GII OVAL RESURFACING PAT 32MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015

    D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·November 15, 2018

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021