BEUDAMED
    85 results · 62ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SkinStylus

    FDA UDI
    Esthetic Medical Inc·00196852554485·The SkinStylus SteriLock® MicroSystem is a powe...

    ROTOPRONE

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH, INC.·Product code IKZ·March 20, 2019

    Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. Models: #96041 Gold Microfil #96042 Green Microfil #96043 Blue Microfil #96044 Set of 3 Microfil (Gold, Green, Blue)

    FDA Recall
    Terminated ·Almore International Inc·Product code EKH·April 20, 2017

    UNKNOWN

    FDA Adverse Event
    Injury ·ROHRER AESTHETICS, INC.·Product code GEX·August 29, 2025

    APEX¿

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM ITALY S.P.A.·Product code KPE·March 19, 2019

    MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.

    FDA Recall
    Terminated ·Merz Aesthetics, Inc.·Product code FMI·December 16, 2011

    Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

    FDA Recall
    Terminated ·Merz Aesthetics, Inc.·Product code LMH·April 6, 2011

    DA VINCI SURGICAL SYSTEMS

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·March 19, 2026

    OSSEOGUARD FLEX

    FDA Adverse Event
    Injury ·COLLAGEN MATRIX, INC.·Product code NPL·December 12, 2025

    GORE-TEX® SUTURE

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code GAW·April 27, 2026

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·February 19, 2025

    SILHOUETTE INSTALIFT

    FDA Adverse Event
    Injury ·SILHOUETTE LIFT INC.·Product code GAM·October 11, 2019

    COPIOS PERICARDIUM MEMBRANE

    FDA Adverse Event
    Injury ·TUTOGEN MEDICAL GMBH·Product code NPL·November 20, 2019

    DAVINCI SI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·April 20, 2023

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·February 19, 2025

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·February 19, 2025

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·February 19, 2025

    SILICONE BREAST IMPLANT

    FDA Adverse Event
    Injury ·SIENTA INC. / TIGER AESTHETICS MEDICAL·Product code FTR·October 30, 2024

    SILICONE TEXTURED GUMMY BEAR BREAST IMPLANTS RIGHT

    FDA Adverse Event
    Injury ·SIENTRA, INC./TIGER AESTHETICS MEDICAL·Product code FTR·January 16, 2025

    SILICONE TEXTURED GUMMY BEAR BREAST IMPLANTS LEFT

    FDA Adverse Event
    Injury ·SIENTRA, INC./TIGER AESTHETICS MEDICAL·Product code FTR·January 16, 2025