9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Genesys Spine Binary® Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EVISION DATA MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN)
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code NCX·September 19, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·June 27, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·August 5, 2011
SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·February 23, 2021
SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·February 22, 2021