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Freedom Wave II

FDA UDI
FREEDOM MEDICAL, INC.·00856698004185·

VISION

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·July 12, 2005

FREEDOM MEDICAL WAVE MATTRESS WITH SMARTWAVE TECHNOLOGY

FDA Adverse Event
Malfunction ·FREEDOM MEDICAL, INC.·Product code FNM·April 24, 2018

FREEDOM MEDICAL WAVE MATTRESS

FDA Adverse Event
Malfunction ·FREEDOM MEDICAL, INC.·Product code FNM·May 16, 2018

FREEDOM WAVE MATTRESS

FDA Adverse Event
Malfunction ·FREEDOM MEDICAL, INC.·Product code FNM·June 25, 2018

Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

FDA Recall
Terminated ·SynCardia Systems Inc.·Product code LOZ·August 6, 2015

FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA. The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels.

FDA Recall
Terminated ·Abbott Diabetes Care, Inc.·Product code NBW·June 10, 2009

Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table

FDA Recall
Open, Classified ·Oakworks Inc·Product code LGX·December 5, 2023

Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table

FDA Recall
Open, Classified ·Oakworks Inc·Product code LGX·December 5, 2023

Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table

FDA Recall
Open, Classified ·Oakworks Inc·Product code LGX·December 5, 2023

Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}

FDA Recall
Open, Classified ·Oakworks Inc·Product code LGX·December 5, 2023

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219

FDA Recall
Terminated ·Oakworks Inc·Product code LGX·June 29, 2021

INPEN MMT-105NNBLNA NOVO NORDISK BLUE

FDA Adverse Event
Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 1, 2021

INPEN MMT-105ELBLNA ELI LILY BLUE

FDA Adverse Event
Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021

INPEN MMT-105ELBLNA ELI LILY BLUE

FDA Adverse Event
Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 1, 2021

INPEN MMT-105ELPKNA ELI LILY PINK

FDA Adverse Event
Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021

INPEN MMT-105ELPKNA ELI LILY PINK

FDA Adverse Event
Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021

INPEN MMT-105NNBLNA NOVO NORDISK BLUE

FDA Adverse Event
Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 2, 2021

INPEN MMT-105ELBLNA ELI LILY BLUE

FDA Adverse Event
Malfunction ·COMPANION MEDICAL INC·Product code FMF·May 26, 2021

INPEN MMT-105ELGYNA ELI LILY GRAY

FDA Adverse Event
Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 1, 2021