BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    Ulthera System (UC-1 Control Unit PRIME Model 2.1)

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

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813057803·STERILE CARBIDE BUR FG330S DARBY

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780384526·Integra® Jarit® Kiene Bone Tamp, 6", 10mm Diameter

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·37613154997641·Bone Screws w. increased head,Cross Pin

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981310394·No-Profile Interbody, 4-Hole Faceplate 18mm

    TISSUE FIXATION SYSTEM

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

    VIVIX-S VW

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    aap Implantate AG·04042409445125·Cannulated Headless Bone Screw 2.5, L 18, TL 4 ...

    VENTRASSIST

    FDA Adverse Event
    Injury ·VENTRACOR·Product code DSQ·November 24, 2008

    MICROSTAAR® INJECTOR CARTRIDGE

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code KYB·September 15, 2011

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·July 26, 2013

    COBAS 8000 C 702 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 20, 2017

    GS CORPATCH

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code MKJ·January 27, 2026

    COBAS 8000 C 702 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 18, 2018

    SENSOR MMT-7040C5 GUARDIAN4 5PK OUS 5

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZP·September 2, 2025

    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·August 28, 2024

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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