8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CANNULAS
FDA 510(k)
FDA Class 1
·Ophthalmic
equilibrium®
FDA UDI
DENTAURUM GmbH & Co.KG·J011790243020·equilibrium® 2 Band bracket with hook, - 7° Tor...
Z5-BL
FDA 510(k)
FDA Class 2
·Dental
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 5, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 15, 2012
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 22, 2015
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024