12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821604160·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973106562·TRIAL 90-SRK-160416 POLY CR 4X16MM
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193024237·B-P MODULAR EXTENSION W/ULTRACOAT - 16 MM X 100 MM
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
ABL835 FLEX ANALYZER WITH PLEURAL PH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 6, 2024
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 20, 2014
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code MAL·June 20, 2011
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012