10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
FDA 510(k)
FDA Class 2
·Orthopedic
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·June 11, 2013
ASR UNI FEMORAL IMPLANT SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026