12 results · 36ms · Sources: EU EUDAMED, US FDA

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JIAJIAN SELF-ADHESIVE ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776365189·Exodontia Oral Davis Root

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036027704·

CORTEK ARTHROSCOPE

FDA 510(k)
FDA Class 2 ·Orthopedic

STERILE POWDERED LATEX SURGEON GLOVES

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

K09-10198 CONVENIENCE KIT

FDA Adverse Event
Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 30, 2009

K09-10198 CONVENIENCE KIT

FDA Adverse Event
Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 30, 2009

FORTIFY ASSURA DR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

COREVALVE 26MM AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 15, 2014

ACCU-CHEK SPIRIT

FDA Adverse Event
Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·May 6, 2011

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