7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
FDA 510(k)
FDA Class 2
·Dental
ULTRASONIC COUPLANT GEL
FDA 510(k)
FDA Class 2
·Cardiovascular
PARAGON TRICHECK ELECTROPHORESIS CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROTECTA CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 6, 2010
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC·Product code NVZ·December 10, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024