10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oasis Lacrimal Intubation Set
FDA 510(k)
FDA Unclassified
·Unknown
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020577·Cruciate Retaining Tibial Insert
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024534·B-P MODULAR EXTENSION W/ULTRACOAT - 10 MM X 175 MM
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ROLL-X GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME 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
GALAXY G3 4MM X 12CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2022
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