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    AFIBALERT ATRIAL FIBRILLATION DETECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809846195·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE MEDIUM-L...

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020

    COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017

    BD SAF-T-INTIMA PRN BL 22GA X 0.75IN

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·August 2, 2024

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 11, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQL·May 23, 2008

    BD BBL¿ CHROMAGAR® MRSA II 100MM (20 EACH)

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSO·May 2, 2023

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·December 29, 2024

    PLATE BBL CHROMAGAR MRSA II 90MM 20 EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSO·June 28, 2021

    BD SAF-T-INTIMA PRN BL 22GA X 0.75IN

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·August 9, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014