36 results
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7ms
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Sources: EU EUDAMED, US FDA
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
FDA Enforcement
Class II
·Ongoing·Ithera Medical Gmbh·February 19, 2025
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
FDA Enforcement
Class II
·Ongoing·EHOB, Inc.·June 30, 2021
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
FDA Enforcement
Class II
·Ongoing·Cook Medical Incorporated·May 22, 2024
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
FDA Enforcement
Class II
·Ongoing·Cook Medical Incorporated·May 22, 2024
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·February 11, 2026
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·July 10, 2024
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
FDA Enforcement
Class II
·Ongoing·Davol, Inc.·August 2, 2023
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
FDA Enforcement
Class II
·Ongoing·ImaCor Inc.·November 6, 2024
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)
FDA Enforcement
Class II
·Ongoing·Davol, Inc.·August 2, 2023
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
FDA Enforcement
Class II
·Ongoing·Davol, Inc.·August 2, 2023
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·May 14, 2025
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024
MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024
MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
FDA Enforcement
Class II
·Ongoing·Angiodynamics, Inc.·March 27, 2024