8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Toricolors (hioxifilcon D) Soft Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101
FDA 510(k)
FDA Class 2
·Cardiovascular
GLIASITE RTS
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 14, 2011
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO·Product code FPO·April 19, 2013
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020