8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ergoline Sunrise 7200 Hybrid Technology
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFANT CARDIAC ARRAY
FDA 510(k)
FDA Class 2
·Radiology
QUANTA SYSTEM DUOLITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANN BLUNT TIP SCREW 4X52MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·May 30, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 18, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 11, 2011
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016