11 results
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33ms
·
Sources: EU EUDAMED, US FDA
EMERGIPACE - EXTERNAL PACEMAKER
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517377234·CoRoent® LO, 8x10x35mm 5°
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776101435·Hook, shaft teeth sharp,
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981124465·14x13x12mm, 7 Degree, Interbody
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·00889981124468·Interbody, 14x13x12mm, 7 Degree, Sterile
Genesys Spine Apache Cervical Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
90XL INSTRUMENTATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARTICUL/EZE BALL 32 +1 GR
FDA Adverse Event
Injury
·3006356043 JOHNSON & JOHNSON MEDICAL·Product code JDI·June 5, 2014
MEGASUTURECUT NEEDLE DRIVER
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 29, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 17, 2015
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013