24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496062035·SCOTTISH 70, SIZE M, NERO, GRADUATED COMPRESSIO...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0620350·6mm H x 20mm W x 35mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X06203580·6mm H x 20mm W x 35mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X062035120·6mm H x 20mm W x 35mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L062035120·6mm H x 20mm W x 35mm L XLIF Trial 12 degree Lo...
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
FDA 510(k)
FDA Class 2
·Cardiovascular
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
FDA 510(k)
FDA Class 2
·Dental
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620350140·Quad Channel Met-Traverse, 35mm x 14mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620350120·Quad Channel Met-Traverse, 35mm x 12mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620350090·Quad Channel Met-Traverse, 35mm x 9mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620350130·Quad Channel Met-Traverse, 35mm x 13mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620350100·Quad Channel Met-Traverse, 35mm x 10mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620350110·Quad Channel Met-Traverse, 35mm x 11mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620350070·Quad Channel Met-Traverse, 35mm x 7mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620350080·Quad Channel Met-Traverse, 35mm x 8mm
HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·HEART VALVES SANTA ANA·Product code LWR·April 16, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·March 18, 2011
MODULAR HEAD/COCR
FDA Adverse Event
Injury
·BIOMET, INC.·Product code JDI·June 6, 2008
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025