BEUDAMED
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    RESPCARE FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Delta(5 oz)-Type V BE & NI Free Non-Precious Ceramic Alloy

    FDA UDI
    STERNGOLD DENTAL LLC·00841549100567·Non-Precious Ceramic Alloy. Delta is a easy to...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809849585·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE MEDIUM...

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837015268·

    MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    WANDY SILICONE CONDUCTIVE RUBBER PAD

    FDA 510(k)
    FDA Class 2 ·Neurology

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    FDA Adverse Event
    Malfunction ·MANNKIND CORPORATION - V-GO·Product code LZG·August 17, 2022

    SYNFRAME RETRACTOR HOLDER- ADJUSTABLE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·May 4, 2023

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 4, 2013

    NA

    FDA Adverse Event
    Injury ·B. BRAUN MEDICAL INC.·Product code NGT·May 16, 2008

    UNKNOWN BONE MORPHOGENTIC PROTEIN

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK·Product code NEK·April 12, 2011

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018