8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAPID NF SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Mobius Elastic Retractor
FDA UDI
Coopersurgical, Inc.·00888937003819·Medium-Large; 10-15 cm Incision Range
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIFE SCOPE EC, MODEL BSM-1102
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 27, 2014
SYNERGY
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPEATIONS CO, MED REL·Product code LGW·October 28, 2010
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 7, 2013
Various products which were contract sterilized.
FDA Enforcement
Class II
·Ongoing·Anewmed Corporation·November 6, 2019