BEUDAMED
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    DX3000-L

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000035136·PROSTHESIS 1133007 CUP PISTON .4X4.0 SST

    Robinson

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490034432·PROSTHESIS 1133007 CUP PISTON .4X4.0 SST

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

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016728·Aluminum oxide dental finishing and polishing a...

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

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883006211·Aluminum oxide dental finishing and polishing a...

    AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    QUIK-COMBO(R) PACING/DEFIBRILLATION/ECG ELECTRODES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MLN·May 29, 2013

    OPTIBOND SOLO PLUS

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·October 1, 2014

    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