8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393591·FERTILITY PACK
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
FDA 510(k)
FDA Class 2
·Cardiovascular
PICCOLO COMPOSITE NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·November 24, 2010
UNKNOWN RIGHT HIP REJUVENATE STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·January 4, 2013
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024