BEUDAMED
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    ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032491·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm C...

    ACE Surgical Silk Bb 3-0 18" Ds24

    FDA UDI
    Surgical Specialties México, S. de R.L. de C.V.·00848782022861·003-2491 Silk Bb 3-0 18" Ds24

    COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MACHNET CAROTIDS COIL ARRAY ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD MICRO-FINE¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code NSC·May 17, 2019

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 29, 2013

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 29, 2011

    RESTYLANE INJECTABLE GEL

    FDA Adverse Event
    Other ·Product code LMH·April 17, 2008

    Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005

    AXIOS STENT AND DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code PCU·October 20, 2016

    AXIOS STENT AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code PCU·October 20, 2016

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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