10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HJY VisualNext Endoscopic Vision System
FDA 510(k)
FDA Class 2
·Neurology
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657006958·Strumpel Forceps, 90 degree, 2.5 x 7mm
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code GIM·May 8, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 26, 2025
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
MEDTRONIC NEUROMODULATION·Product code MHY·July 29, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018