12 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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