BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    ViZion DR + Wireless

    FDA 510(k)
    FDA Class 2 ·Radiology

    eTRAX™ Needle

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436103357·Sterile needle, 16GA x 8cm with (7.6 tapered to...

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024657·B-P MODULAR EXTENSION W/ULTRACOAT - 10 MM X 200 MM

    ELECSYS C-PEPTIDE CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·February 6, 2026

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·October 10, 2014

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·July 7, 2011

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    GUIDANCE HANDPIECE

    FDA Adverse Event
    Malfunction ·HALT MEDICAL, INC.·Product code HFG·November 22, 2016

    ERBE ICC 200 EA

    FDA Adverse Event
    Injury ·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·April 30, 2019

    COMPREHENSIVE® REVERSE SHOULDER CENTRAL SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 23, 2024

    COMPREHENSIVE® REVERSE SHOULDER FIXED LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 23, 2024

    COMPREHENSIVE® REVERSE SHOULDER FIXED LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 23, 2024

    HYBRID GLENOID TITANIUM POST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·January 12, 2018

    HYBRID GLENOID BASE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·January 12, 2018

    FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016