10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA II PORCELAIN POLISHING PASTE
FDA 510(k)
FDA Class 1
·Dental
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756657402·CYSTOSCOPY PACK
HI CHEM CREATININE REAGENT (PRODUCT #88809)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STERILE LACERATION TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NOVATION GXL
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 13, 2022
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC·Product code NBW·May 20, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 20, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015