10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEOVIEW Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
SHIKANI SPEAKING VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
FDA 510(k)
FDA Class 1
·Ophthalmic
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 4, 2019
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code NIQ·December 8, 2006
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
SMALLBORE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·July 23, 2014
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·June 16, 2011
SELOX JT 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·October 20, 2016
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017