7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
FDA 510(k)
FDA Class 1
·Microbiology
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
FDA 510(k)
FDA Class 2
·Radiology
RSV (RADIOLOGY SYSTEM VISIODENT
FDA 510(k)
FDA Class 2
·Dental
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
ENDOPATH XCEL STABILITY SLEEVE FOR BLADELESS TROCAR-12MM DIAMETER, 100MM LENGTH
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GCJ·December 17, 2007
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 14, 2012
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