8 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IF8000
FDA 510(k)
FDA Class 2
·Physical Medicine
Monolith
FDA UDI
Nuvasive, Inc.·00887517677044·Monolith Core, Ø12x41mm
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AutoStrut
FDA 510(k)
FDA Class 2
·Orthopedic
APEX HOLE ELIM POSITIVE STOP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·March 6, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·August 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024