10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ETHICON ENDOSUTURE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABBOTT ARCHITECT HAVAB-M
FDA 510(k)
FDA Class 2
·Microbiology
ALINITY I HAVAB IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·March 26, 2026
MENTOR MEMORYGEL XTRA BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·June 25, 2024
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 19, 2014
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·February 15, 2013
TURON SHOULDER INSTRUMENT
FDA Adverse Event
Malfunction
·ENCORE MEDICAL, L.P.·Product code KWS·December 14, 2010
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·February 6, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024