355 results · 15ms · 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

IDM-MICRO-R. Electrical wheelchair component.

FDA Enforcement
Class I ·Ongoing·mo-Vis BVBA·September 10, 2025

IDM-ARLITE-R. Electrical wheelchair component.

FDA Enforcement
Class I ·Ongoing·mo-Vis BVBA·September 10, 2025

All-round Joystick R-net Light. Electrical wheelchair component.

FDA Enforcement
Class I ·Ongoing·mo-Vis BVBA·September 10, 2025

IDM-MULTI-R. Electrical wheelchair component.

FDA Enforcement
Class I ·Ongoing·mo-Vis BVBA·September 10, 2025

Micro Joystick R-net. Electrical wheelchair component.

FDA Enforcement
Class I ·Ongoing·mo-Vis BVBA·September 10, 2025

Multi Joystick R-net. Electrical wheelchair component.

FDA Enforcement
Class I ·Ongoing·mo-Vis BVBA·September 10, 2025

Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

FDA Enforcement
Class II ·Ongoing·mo-Vis BVBA·January 17, 2024

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