13 results · 26ms · Sources: EU EUDAMED, US FDA

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reVive Light Therapy Essentials

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RELION INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 4, 2020

SYRINGE 1.0ML 31G 6MM S/C U-100 RELION

FDA Adverse Event
Injury ·BD MEDICAL - DIABETES CARE·Product code FMF·April 6, 2021

A-LINE AEP MONITOR

FDA 510(k)
FDA Class 2 ·Neurology

RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 12, 2011

ADULT CURL CATH 1CUFF

FDA Adverse Event
Malfunction ·TYCO HEALTHCARE/KENALL·Product code FJS·June 30, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

EA DELTA CER INSERT 36IDX54OD

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code MRA·June 5, 2023

EA DELTA CER INSERT 36IDX54OD

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 1, 2023

XVWEB

FDA Adverse Event
Injury ·PLANET DDS·Product code LLZ·March 13, 2025

SECOND OPINION

FDA Adverse Event
Injury ·PEARL INC.·Product code MYN·March 13, 2025

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