BEUDAMED
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    ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A

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

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017626·Hook Punch Cut angular 3.5mm 45 degree left

    PFC SIGMARP STB TB IN 2.5 10.0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NJL·December 4, 2019

    DIAMONDBACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRE-LOADED BIOSTINGER HORNET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOGIC TIBIA PS MOD INSRT SZ 4 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 10, 2024

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 20, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·June 2, 2011

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025