7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GLUCOSE TOLERANCE BEVERAGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EXPD 4343D; EXPD 3643D
FDA 510(k)
FDA Class 2
·Radiology
SPEEDBAND SUPERVIEW SUPER 7¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·January 29, 2013
PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 20, 2010
PRK LASER
FDA Adverse Event
Injury
·LASIK PLUS·Product code HQF·July 9, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024