BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Tx™

    FDA UDI
    INNO Holdings, Inc.·M711LS39709050·Ti 6Al 4V (ELI)

    Star Tissue Marker

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

    ENDOSSEOUS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 21, 2013

    ZIMMER BIGLIANI FLATOW DRILL GUIDE

    FDA Adverse Event
    Malfunction ·ZIMMER INC·Product code HSD·January 4, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 31, 2014

    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