BEUDAMED
    19 results · 34ms · Sources: EU EUDAMED, US FDA

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    FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Trumpf Medical

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761984516·Remote control PST 500 W U

    Control Units PST500

    FDA UDI
    Baxter Medical Systems GmbH + Co. KG·00887761973602·Remote control PST 500 W U

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699777·Fully Guided Drill Ø3.75mm L20mm

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180502068·PLIF/TLIF Rotating Disc Shaver/Distractor Combo...

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981117122·Locking Screw Inserter, Long

    REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    WALLSTENT BILIARY ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TRIO LX SMALL CONNECTOR

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 1, 2023

    D131 KIDS INFANT ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·May 20, 2026

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·April 22, 2013

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD, INC.·Product code BTR·April 18, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 9, 2008

    D131 KIDS INFANT ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL.·Product code DTM·September 26, 2024

    D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·June 18, 2019

    D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code DTM·February 3, 2016

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024