BEUDAMED
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    ENDOHELIX ENDARTERECTOMY DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Brava

    FDA UDI
    Coloplast A/S·05708932702607·Brava® Protective Sheet. 4 x 4 in

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10887488134925·STERILE DRSG CHNG,BIOPATCH KIT

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00811801034305·Curette, Cup, Left Angled Up, Straight, Size 4

    SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 14, 2015

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·FLEXTRONICS EMS CANADA·Product code FNL·March 6, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 28, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·April 18, 2008

    BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)

    FDA Recall
    Terminated ·BD Diagnostic Systems·Product code GSY·October 20, 2004

    Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024