BEUDAMED
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    NEOV DIODE LASER FAMILY

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

    Robinson

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490034425·PROSTHESIS 1133006 CUP PISTON .4X4.5 SST

    Contours™ Finishing & Polishing Discs Refill Pack 1/2" Fine

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016711·Aluminum oxide dental finishing and polishing a...

    Contours™ Finishing & Polishing Discs Refill Pack 1/2" Fine

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883006204·Aluminum oxide dental finishing and polishing a...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330060·Rod Bender, 5.5 mm, 3 Position

    I-FUSE HAMMER TOE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    DYNESYS SCREW GENERIC

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code NQP·May 16, 2013

    OPTIBOND SOLO PLUS

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code KLE·June 17, 2011

    HNM LATERAL ANCHOR

    FDA Adverse Event
    Injury ·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·January 29, 2020

    Glucose Hex reagent, sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L .

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CFR·June 7, 2006

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015