BEUDAMED
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    ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROLLO 210X30X16I.OP(BARASHED)

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763005599·

    2040 Ceramic Brackets

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746005091·COSMETIC 20/40 UL BIC 018 T-7 A=0 R2D

    TMA - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989024647·ARCH LO-FRICT.TMA UP 19 X25 PK/10

    Humeris Shoulder

    FDA UDI
    FX SOLUTIONS·03701037304440·TRIAL HUMERIS STEM T08

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193106984·HA PEEK EVOS Straight, ,8mmx8mmx 26mm , BICONVE...

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795111203·Gorilla R3CON, Drill Guide, Centering, 3.5mm Co...

    STS RANGE , MODELS STS20,STS30,STS40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AUTO ENDO5 ML

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·August 8, 2017

    OPTETRAK LOGIC KNEE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 7, 2024

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·March 20, 2013

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code JJE·March 16, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·March 26, 2008

    CERAMENT BONE VOID FILLER

    FDA Adverse Event
    Injury ·BONESUPPORT AB·Product code MQV·April 26, 2024

    CERAMENT BONE VOID FILLER

    FDA Adverse Event
    Injury ·BONESUPPORT AB·Product code MQV·April 26, 2024

    BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 Needle Free Valves, REF: 20062E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20159E7D; BD Alaris GP Series SmartSite Burette Set, REF: 60103E; BD Alaris GP Series Burette Set No Filter, REF: 63441E; Alaris SmartSite needle-free valve, REF: 2000E7D

    FDA Enforcement
    Class II ·Ongoing·CAREFUSION·September 22, 2021

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014