9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KANEDA SR ANTERIOR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902974427·INSTRUMENT 6971248 IMP TRIAL 8X14MM
PEEK Corpectomy
FDA UDI
Nuvasive, Inc.·00887517623386·PEEK Corp Core, Ø12x48mm
SECUTE ELBOW BAND
FDA 510(k)
FDA Class 1
·Physical Medicine
SILICONE IMPRESSION MATEOIAL
FDA 510(k)
FDA Class 2
·Dental
DUAL COOLER/HEATER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·February 1, 2013
LID FOR RECON SAGITTAL SAW FOR TRAUMA RECON SYSTEM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·July 31, 2014
PROFEMUR(R) S ALPHA HIP STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·January 26, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024