12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sense System with IBT Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Empower Clear Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746199905·COSMETIC SL EMPOWER CLEAR INTERACT UL CEN 018 T...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746000256·COSMETIC SL EMPOWER CLEAR INTERACT UL CENTRAL 0...
Empower Clear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746154027·COSMETIC SL EMPOWER CLEAR INTERACT UL CEN 018 T...
DRILL BIT
FDA UDI
Biomet Orthopedics, LLC·00887868022548·
FB Broach Handle 135
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215040741·
CRITICOOL PRO
FDA 510(k)
FDA Class 2
·Cardiovascular
T2 XVBR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 21, 2013
R50N RECORDER
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL SYSTEMS, INC. (IT/M)·Product code DSI·June 23, 2011
DIMENSION EXL W/LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·October 17, 2014
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026