7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sofia 2 Lyme FIA, Sofia Lyme Control Set
FDA 510(k)
FDA Class 2
·Microbiology
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTILITE HOLMIUM LASER FIBERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLUM A+ DRIVER EDITI
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025