10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA CHEM BUN-UV #65080-65081
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127027406·Low Rider Reamer, Size 41
Jumong General
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·August 19, 2013
V.A.C. THERAPY
FDA Adverse Event
Injury
·KCI USA, INC.·Product code OMP·May 7, 2014
PROMUS ELEMENT ¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 13, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIVISION·Product code FNL·September 2, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025