13 results
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28ms
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Sources: EU EUDAMED, US FDA
EG-3870UTK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776365172·Exodontia Oral Root Teaser #38,
Y-CLIC ADAPTER
FDA UDI
Promepla·03700512901969·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036027698·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450029305·
CORTEK CYSTOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
FDA 510(k)
FDA Class 2
·General Hospital
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 15, 2025
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
FORTIFY ASSURA DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 15, 2014
ACCU-CHEK RAPID D
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·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