BEUDAMED
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    BARI-KAD PACKING DEVICE

    FDA 510(k)
    FDA Class 1 ·Dental

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306800580·Kaye Scissors, Curved, Ribbon, 11.5cm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450482872·

    Inverted Reamer-AO ø 42

    FDA UDI
    Spierings Orthopaedics B.V.·08720256027195·

    PRIMA OXYGEN MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AEQ REV II GLENOID BASEPLATE DIA 25MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code PHX·July 1, 2025

    AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·March 13, 2025

    AEQ REV GLENOID BASEPLATE 29MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·March 6, 2025

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD P/N 70-0050-318) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    FR3, REFURB ECG AED, LANGUAGE CONFIGURAB

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2013

    GYNEMESH POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·UNK·Product code FTL·April 6, 2011

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·May 22, 2008

    AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·March 25, 2024

    D.4,5MM COMPRESSION SCREW L.32MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

    D.4,5MM COMPRESSION SCREW L.23MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 7, 2025

    AEQ REV GLENOID BASEPLATE 29MM

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·May 21, 2024

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD P/N 70-0050-318) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Recall
    Terminated ·Xeridiem Mediem Medical Devices Inc·Product code PIF·December 23, 2015

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018