357 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 28, 2023
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 28, 2023
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
FDA Enforcement
Class II
·Ongoing·BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.·March 5, 2025
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.
FDA Enforcement
Class II
·Ongoing·Quidel Corporation·February 21, 2024
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
FDA Enforcement
Class II
·Ongoing·Healthmark Industries Co., Inc.·May 6, 2026
Lamicel 10PK 10MM INTL
FDA Enforcement
Class II
·Ongoing·Medtronic Xomed, Inc.·January 1, 2020
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
FDA Enforcement
Class II
·Ongoing·Cellex·September 22, 2021
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
FDA Enforcement
Class II
·Ongoing·IDS LTD·January 15, 2025
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
LIFEPAK 35 ECG cable REF 11111-000041
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·February 12, 2025
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
FDA Enforcement
Class II
·Ongoing·CardioQuip, LLC·October 13, 2021
Medicina Oral Tip Syringe 0.5ml Code: OT005
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina Reusable Oral syringe 2.5ml Code: OTH25
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiopulmonary Gmbh·August 6, 2025
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
FDA Enforcement
Class II
·Ongoing·CardioQuip, LLC·October 13, 2021
Lamicel 20PK 5MM INTL
FDA Enforcement
Class II
·Ongoing·Medtronic Xomed, Inc.·January 1, 2020