25 results · 29ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

FDA Recall
Open, Classified ·Argon Medical Devices, Inc·Product code DTK·September 12, 2025

CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.

FDA Recall
Open, Classified ·B. Braun Medical, Inc.·Product code FPA·September 15, 2022

ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets

FDA Recall
Open, Classified ·B. Braun Medical, Inc.·Product code FPA·September 15, 2022

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.

FDA Recall
Open, Classified ·B. Braun Medical, Inc.·Product code FPA·September 15, 2022

DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MSD·March 18, 2024

6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

FDA Recall
Open, Classified ·ICU Medical, Inc.·Product code FMG·August 1, 2022

8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;

FDA Recall
Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022