7 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
FDA 510(k)
FDA Class 2
·Radiology
ACON TRI-FECT DRUG SCREEN TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DUROM US ACETABULAR COMPONENT 50/44 J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·December 17, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 27, 2012
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016