11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58280940170·ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Ambassador
FDA UDI
Choice Spine, LP·10885862263117·
H-SCRIBE
FDA 510(k)
FDA Class 2
·Cardiovascular
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
FDA 510(k)
FDA Class 2
·Immunology
AXXENT FLEXISHIELD MINI (K090417)
FDA Adverse Event
Injury
·XOFT, INC.·Product code IXI·January 7, 2011
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 6, 2013
CAD II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 16, 2014
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 20, 2011
MESH ¿ VENTRALEX
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 2, 2024
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