176 results
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8ms
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Sources: EU EUDAMED, US FDA
Temporary Titanium Abutments
FDA Enforcement
Class II
·Ongoing·DDS Lab·February 12, 2025
BD Kiestra" ReadA; Catalog No.: 446948.
FDA Enforcement
Class II
·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026
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
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation.
FDA Enforcement
Class II
·Ongoing·ORTOMA AB·October 1, 2025
LUCAS 2, 3 and 3.1 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·July 2, 2025
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.
FDA Enforcement
Class II
·Ongoing·HemoCue AB·July 9, 2025
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
FDA Enforcement
Class II
·Ongoing·Cellavision AB·June 20, 2018
EVA Floor Lifts, Model Numbers: 400, 450, 600
FDA Enforcement
Class II
·Ongoing·Handicare AB·May 20, 2020
Omnera 400A Digital Radiographic System
FDA Enforcement
Class II
·Ongoing·Arcoma AB·July 13, 2022
Omnera 400T Digital Radiographic System
FDA Enforcement
Class II
·Ongoing·Arcoma AB·July 13, 2022
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Phadia Ab·January 31, 2024
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
FDA Enforcement
Class II
·Ongoing·Cellavision AB·November 26, 2025
The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty contractors, the RTS873 streamlines layout processes, reduces rework, and enhances overall productivity.
FDA Enforcement
Class II
·Ongoing·Trimble Ab·May 7, 2025
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
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
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
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