BEUDAMED
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    OSSIX PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    OSSIX BONE, OSSIX PLUS

    FDA Adverse Event
    Injury ·DATUM DENTAL LTD.·Product code NPM·June 22, 2022

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776085810·Senning Vascular Suction

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486020606·ACETABULAR REAMER ¿ 62mm

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017804·K-Wire, Double Ended, Trocar Point, Diameter Si...

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221045027·Unitek(TM) Molar Band General Purpose Narrow Re...

    Denovo general purpose dental molar band

    FDA UDI
    Denovo Dental, Inc.·00810059290747·Denovo general purpose dental molar band - Mand...

    DIGNITY POWER INJECTABLE TITANIUM PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VS-800 VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 4, 2020

    BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 20, 2024

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 10, 2013

    SYNCHRON LX 20 PRO SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 2, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 26, 2022

    STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a Stckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWC·August 1, 2014

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024