BEUDAMED
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    CERAMIC(TM) ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909132552·REVELATION DIAMOND 859-014VF - 5 PACK

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110898·TIP GUARDS VENTED YELLOW PACK OF 100

    SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PUREGRAFT 850/PURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·January 14, 2013

    ENSEAL TRIO

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code GEI·November 23, 2010

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2014

    Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 20, 2017

    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·June 8, 2016

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017