BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983141·posteriors; shade BL2; size M; lower jaw

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111450105·LIM MICRO JAW SUT NH CV W LOCK

    SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LINK MP Monoblock Hip Prosthesis

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016

    ELECTROSURGERY PROBE PLUS II

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·February 28, 2013

    REAGENT RED BLOOD CELLS BIOTESTCELL-I11

    FDA Adverse Event
    Malfunction ·BIO-RAD MED DIAGNOSTICS GMBH·Product code KSZ·January 17, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HWC·August 6, 2014

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 31, 2025

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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