9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tapestry Biointegrative Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
FDA 510(k)
FDA Class 2
·Neurology
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRULIANT TIB IMP PS INSERT SZ 5 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 4, 2024
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 30, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
2.4MM TI VA-LCP 2-CLMN VLR DSTRADIUS PL 7H HD/2H SHAFT/LT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·July 11, 2013
VERSE POLY DRIVER SHAFT NAV
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code OLO·April 29, 2022
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025