9 results
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17ms
·
Sources: EU EUDAMED, US FDA
PFEIFFER METERED DOSAGE SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
Secure IM Nail
FDA UDI
A.M. SURGICAL, INC.·00857915007293·One 70mm x 1.6mm IM Nail
TOTAL BILIRUBIN REAGENT, CONCENTRATED
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CRYPTOSPORIDIUM CONTROL SLIDE
FDA 510(k)
FDA Class 1
·Microbiology
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC·Product code NBW·May 20, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
EGIA ULTRA UNIVERSAL XL STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY U.S. SURGICAL·Product code GDW·December 27, 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