12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROCO
FDA 510(k)
FDA Class 2
·Anesthesiology
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690122678·Modular Stem 19mm x 75mm
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981095017·Occiptal Rod Template, 60 Degrees
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Estremo Fibular Nail
FDA 510(k)
FDA Class 2
·Orthopedic
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION SYSTEMS·Product code GZB·June 27, 2014
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013
PCA PLS II
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·December 9, 2010
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Recall
Open, Classified
·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025