274 results · 7ms · Sources: EU EUDAMED, US FDA

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Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

FDA Enforcement
Class II ·Ongoing·Human Care Hc Sweden Ab·April 17, 2024

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

FDA Enforcement
Class II ·Ongoing·Jolife AB·May 20, 2026

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

Food Intolerance Test Small

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Lactose Intolerance Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Mycotoxin Panel Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Fructose Intolerance Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

FDA Enforcement
Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

Intestinal Worms Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Iodine Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No

FDA Enforcement
Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026

Menopause (FSH) 2 Tests

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Biological Age & Longevity Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Iron Deficiency Test (ferritin)

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Men s Hormone Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

IBS Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Gut Microbiome Test Medium

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Candida Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Organic Acids Profile Test Large

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Pet Allergy Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025