13 results
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19ms
·
Sources: EU EUDAMED, US FDA
AMNIO CENTESES KIT W/NEEDLE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88300191·Max. 1. Molar band W-Fit right 19
LEONE SPA
FDA UDI
LEONE SPA·08033707028321·WEB 1ST MOLAR BANDS n.UL 19
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88300190051·Max. 1. Molar band W-Fit right 19
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88300190101·Max. 1. Molar band W-Fit right 19
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88300190501·Max. 1. Molar band W-Fit right 19
J-SCREW COMPRESSION SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SCOPE CABLE EXERA II
FDA Adverse Event
Malfunction
·OLYMPUS MED SYS CORP·Product code FDF·March 13, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 13, 2012
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2015
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·November 4, 2015