BEUDAMED
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    STRYKER TEMPORARY CONDYLAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000035259·PROSTHESIS 1133285 LIPPY CUP PSTN .4X4.5

    Lippy

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490034654·PROSTHESIS 1133285 LIPPY CUP PSTN .4X4.5

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517637093·CoRoent Ant TLIF PEEK, 13x13x28mm 15°

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

    CLYDESDALE PTC SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019

    DIXTAL DZ-4100 SERIES PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LDR SPINE USA AVENUE L INTERBODY FUSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 19, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    4D INTEGRATED TREATMENT CONSOLE

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·May 12, 2011

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 21, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    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

    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