11 results
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20ms
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Sources: EU EUDAMED, US FDA
Tina-quant Cardiac high sensitivity CRP III
FDA 510(k)
FDA Class 2
·Immunology
Macan
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950029662·ULTRA FLEX BENDABLE ELECTRODE
LEONE SPA
FDA UDI
LEONE SPA·08033707023500·CALIBRA BANDS 2ND MOLAR n.SLR 26
n/a
FDA UDI
Ortho Development Corporation·00822409079469·Mod Liner Impactor 26mm
KOBY SURGICAL INTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Disposable ECG Cable
FDA 510(k)
FDA Class 2
·Cardiovascular
Trilogy®
FDA UDI
Zimmer, Inc.·00889024120167·
PFC SIGMA MOD TIB TRAY CEM SZ2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 9, 2008
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 26, 2011
SURGMASTER
FDA Adverse Event
Malfunction
·OLYMPUS OF AMERICA·Product code FAS·July 26, 2013
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 12, 2018