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

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Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·June 12, 2024

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

FDA Enforcement
Class II ·Ongoing·Covidien·August 28, 2024

StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

FDA Enforcement
Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020