BEUDAMED
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    SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821051035·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399005038·SST TWIST DRILL, DENTAL, 3.5mm Dia. x 79mm

    Paratrooper™ Plantar Plate Repair System

    FDA UDI
    Paragon 28, Inc.·00889795105905·Plantar Plate, Suture Retreiver, Assembly

    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIMENSION DRUG CALIBRATOR, MODEL DC22B

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ST360 SPINAL FIXTION SYSTEM

    FDA Adverse Event
    Malfunction ·ZIMMER SPINE, INC.·Product code MCV·December 29, 2006

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·April 10, 2013

    VECTRA GEN 2C COMBO WITHOUT EMG

    FDA Adverse Event
    Injury ·DJ ORTHOPEDICS DE MEXICO·Product code IMG·April 4, 2011

    QUICKSITE LV

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-05103. 5 mm x 100 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. The Innova Self-Expanding Stent is available in a variety of diameters and lengths. The delivery system is also offered in two working lengths (75 cm and 130 cm). The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NIP·May 19, 2011

    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