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MICRO THIN-PII, #0523

FDA 510(k)
FDA Class 3 ·Cardiovascular

MICROTHIN-PII BIPOLAR PULSE GEN. #0623

FDA 510(k)
FDA Class 3 ·Cardiovascular

MICROTHIN-PII BIPOLAR PULSE GEN. #0621

FDA 510(k)
FDA Class 3 ·Cardiovascular

45 DEGREE LT ARTHROPASSER PII

FDA Adverse Event
Injury ·BIOMET SPORTS MEDICINE·Product code NBH·July 13, 2016

MICROTHIN P-II BIPOLAR PULSE GENERATOR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS·Product code DXY·September 8, 1997

MICROTHIN P-II UNIPOLAR PULSE GENERATOR

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS·Product code DXY·May 8, 1997

MICROTHIN P-II BIPOLAR PULSE GENERATOR

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS·Product code DXY·January 16, 1997

MICROTHIN P-II BIPOLAR PULSE GENERATOR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS·Product code DXY·January 16, 1997

MICROTHIN P-II BIPOLAR PULSE GENERATOR

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS·Product code DXY·January 16, 1997

MICROTHIN P-II UNIPOLAR PULSE GENERATOR

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS·Product code DXY·March 6, 1997

MICROTHIN P-II UNIPOLAR PULSE GENERATOR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS·Product code DXY·November 7, 1997

T2CANDIDA 1.1 PANEL

FDA Adverse Event
Malfunction ·T2 BIOSYSTEMS, INC·Product code PII·September 30, 2022

PROPONENT MRI DR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·October 6, 2023

EMBLEM MRI S-ICD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·February 4, 2022

IMPLANTABLE DEVICE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DXY·February 1, 2021

ACCOLADE

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·March 19, 2018

RESONATE HF CRT-D

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NIK·November 29, 2024

PROPONENT MRI DR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·November 22, 2024

ACCOLADE? MRI EL DR

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·January 30, 2026

RESONATE X4 CRT-D

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NIK·May 26, 2022