10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OcuMet Beacon (OCUB100)
FDA 510(k)
FDA Class 2
·Ophthalmic
LCP
FDA UDI
Synthes GmbH·10886982167743·3.5MM LCP T-PLATE 3H HEAD/ 3H SHAFT/52MM-OBLIQU...
BD INSYTE¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·May 15, 2018
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
FDA 510(k)
FDA Class 2
·Radiology
LYRA ADENOVIRUS ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·February 1, 2011
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
2520274-2013-04589
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 22, 2013
S-ICD SYSTEM
FDA Adverse Event
Malfunction
·CAMERON HEALTH·Product code LWS·November 22, 2015
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024