16 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stealth-Midas System
FDA 510(k)
FDA Class 2
·Neurology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821607130·
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024565·B-P MODULAR EXTENSION W/ULTRACOAT - 13 MM X 175 MM
PROCEED SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WATERPAP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 30, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2008
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2020
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·July 19, 2019
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 14, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 30, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·May 28, 2020
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 26, 2018
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·September 17, 2019
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