11 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295090182·BALL 22mm
XTERRA GT POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
FDA 510(k)
FDA Class 2
·Ophthalmic
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MED - NEUROMODULATION·Product code GZB·October 24, 2014
LINOX SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·July 12, 2011
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026