BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Richard Wolf GmbH·04055207065426·CLEANING BRUSH Ø 5MM TL 700MM for channel Ø 3,...

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970705·anteriors; shade D3 light; mould BOS

    Tx™

    FDA UDI
    INNO Holdings, Inc.·M711LS39707050·Ti 6Al 4V (ELI)

    MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARIX Wrist System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·June 2, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 20, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 25, 2011

    TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.

    FDA Enforcement
    Class II ·Ongoing·Innovasis, Inc·September 25, 2024