10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW QUADPOLAR MAPPING/PACING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909110652·REVELATION DIAMOND 886-016C - 5 PACK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393737·PODIATRY PACK
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k)
FDA Class 2
·Neurology
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·January 4, 2013
TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 24, 2010
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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