14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517287472·CoRoent® XL-CTW, 12x22x45mm, 10°
CoRoent
FDA UDI
Nuvasive, Inc.·00887517300164·CoRoent® XLK, 12x18x45mm 10°
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024400535·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970386·
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046484·LATERAL TRIAL, WIDE, STANDARD, 12mm X 23mm X 45mm
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
FDA 510(k)
FDA Class 2
·Neurology
DEGOTZEN SYNCHRO
FDA 510(k)
FDA Class 2
·Dental
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·November 5, 2008
ADVANCE 18 LP LOW PROFILE BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·COOK, INC.·Product code DQY·August 17, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 11, 2013
COPAN WASP/COLIBRI
FDA Adverse Event
Other
·COPAN WASP·Product code QQV·July 25, 2024
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026