BEUDAMED
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    PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACE OPEN-BACK HALO RING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LASERTRIPTER MINISCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PSO KNEE BONE SUBSTITUTION

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRO·April 22, 2022

    PSO KNEE BONE SUBSTITUTION

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRO·July 18, 2019

    MORPHEUS PICC

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code LJS·June 11, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·February 22, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 16, 2018

    NFORCE NITINOL HELICAL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FFL·June 13, 2019

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024

    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

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 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