354 results · 13ms · Sources: EU EUDAMED, US FDA

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Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

FDA Enforcement
Class II ·Ongoing·Zoe Medical Incorporated·September 18, 2024

Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

FDA Enforcement
Class II ·Ongoing·Zoe Medical Incorporated·September 18, 2024

VACUETTE SAFELINK, REF: 450210

FDA Enforcement
Class II ·Ongoing·Greiner Bio-One GmbH·January 15, 2025

VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

FDA Enforcement
Class II ·Ongoing·Greiner Bio-One North America, Inc.·January 24, 2024

VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

FDA Enforcement
Class II ·Ongoing·Greiner Bio-One North America, Inc.·July 24, 2024

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

FDA Enforcement
Class II ·Ongoing·Greiner Bio-One North America, Inc.·November 5, 2025

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

FDA Enforcement
Class II ·Ongoing·Greiner Bio-One North America, Inc.·November 26, 2025

Lazervida 10W diode laser cutter and engraver with Lazervida shield.

FDA Enforcement
Class II ·Ongoing·Flux Technology Inc.·June 11, 2025

RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. 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: 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

Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·June 28, 2023

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B 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: 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: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

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

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