47 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ARTERIOVENOUS BLOOD TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHYSICA - PATELLAR PEGS DRILL
FDA Adverse Event
Malfunction
·LIMACORPORATE·Product code JWH·April 1, 2021
BIODRIVE CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WELL-TENS
FDA 510(k)
FDA Class 2
·Neurology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 1, 2007
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 24, 2012
Hemashield Gold Woven and Knitted Double Vascular Grafts.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010
Hemashield Platinum Woven Double Velour TAAA Vascular Grafts.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010
Hemashield Gold Woven Double Velour Vascular Branch Graft
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSY·May 24, 2010
Hemashield Double Velour Cardiovascular Fabrics.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DXZ·May 24, 2010
Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSZ·May 24, 2010
Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MAL·May 24, 2010
Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufactured and distributed by Maquet Corporation San Jose, CA
FDA Recall
Terminated
·CTS, Inc. dba Guidant Cardiac Surgery·Product code GCJ·February 5, 2009
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·September 20, 2024
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·September 19, 2023
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DXC·August 15, 2025
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DXC·August 15, 2025
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DXC·August 15, 2025
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·February 9, 2022