BEUDAMED
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    MICROMED QRS CARD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Swish™ Straight Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116387·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111216428·GRAVES SPEC LG W/GOLD SCREWS

    RayPilot System

    FDA 510(k)
    FDA Class 2 ·Radiology

    THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUADRA ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·January 9, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-CLONMEL·Product code NIQ·November 20, 2010

    Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·September 12, 2012

    Active INTACT PTH, Part Number: DSL-8000 The DSL-80000 ACTIVE Intact PTH IRMA Kit provides materials for the quantitative measurement of Intact PTH (I-PTH) in serum or plasma. The assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEW·April 22, 2010

    Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEW·April 22, 2010

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024