BEUDAMED
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    Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Humeris Shoulder

    FDA UDI
    FX SOLUTIONS·03701037303245·HUMERIS STEM TA6V SIZE 09 CEMENTED

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450011287·

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023803·B-P MODULAR EXTENSION W/ULTRACOAT - 9 MM X 25 MM

    Ontrak

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129261·CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX

    Ontrak

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129629·CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX

    OnTrak

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522102547·CUFF,ABP,XLGADLT,38-50CM/15-20IN,NO LTX,QKD/LEUR

    Coaxial needle

    FDA UDI
    Möller Medical GmbH·04260277177898·

    LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OMI RETRACTABLE SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 13, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 13, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWP·October 10, 2014

    LMA MADomizer, Rx only, 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

    Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025