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    NikoClips

    FDA UDI
    NIKOMED USA·10853512006629·Adapter clips for ECG diagnostic and monitoring...

    NikoClips

    FDA UDI
    NIKOMED USA·10853512006612·Adapter clip for ECG diagnostic and monitoring ...

    ACCUCATH ACE INTRAVASCULAR CATHETER

    FDA Adverse Event
    Injury ·BARD REYNOSA S.A. DE C.V.·Product code FOZ·November 1, 2024

    GALLANT HF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NIK·February 20, 2023

    GALLANT HF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NIK·May 30, 2023

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·January 31, 2013

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 16, 2023

    UNK GEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·October 13, 2023

    PLATINIUM

    FDA Adverse Event
    Malfunction ·MICROPORT CRM S.R.L.·Product code NIK·May 13, 2024

    ACCUCATH ACE INTRAVASCULAR CATHETER (18G)

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code FOZ·December 26, 2024

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    FDA Adverse Event
    Death ·CORDIS NEUROVASCULAR, INC.·Product code HCG·March 22, 2013

    DRILL BIT CANN AO 2.0X65MM NS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·August 22, 2018

    VARIABLE PITCH COMPRESSION SCREW 2.5X16MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·June 12, 2018

    EXTERNAL NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·February 8, 2024

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 16, 2017

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA classification
    FDA Class 3 ·Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code NIK·February 9, 2005

    Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).

    FDA Recall
    Terminated ·Product code NIK·June 17, 2005

    These models are not available in the US. Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·May 15, 2006

    CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·March 23, 2007