7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RANDOX DIRECT LDL CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Xperius Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWY·February 28, 2013
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·January 11, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 6, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024