10 results · 22ms · Sources: EU EUDAMED, US FDA

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NextAR™ Spine Platform

FDA 510(k)
FDA Class 2 ·Neurology

NEXTAR SPINE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

METAL OPAQUER

FDA 510(k)
FDA Class 2 ·Dental

THE LIBERATOR WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

ANESTHESIA ARMBOARD DEVICE

FDA Adverse Event
STERIS CORPORATION - MONTGOMERY·Product code FQO·October 29, 2014

MAXCEM ELITE

FDA Adverse Event
Injury ·KERR CORPORATION·Product code EMA·August 12, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

ALINITY I TOXO IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·November 18, 2024

StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - 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

EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015