13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPINAUT-V, SPINAUT-S, SPINAUT-I
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131288035·H330V2, DESIGNRITE 10 WL SOR HHM
ProLift
FDA UDI
Life Spine, Inc.·00190837117474·
Pro Lift Instruments
FDA UDI
Life Spine, Inc.·00190837031091·
RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·March 26, 2013
CONTOUR USB
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
CONTOUR NEXT
FDA Adverse Event
Injury
·BAYER HEALTHCARE LLC·Product code NBW·July 27, 2012
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 6, 2011
PROMOS INCLINATION SET 20MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSD·June 7, 2013
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·October 8, 2014
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018