10 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198451·AK3 Ultra Insert Trial Size 1, 14mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123083·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 100mm
Game Ready GRPro 2.1 System
FDA 510(k)
FDA Class 2
·Physical Medicine
EMIT-BARBITURATE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 10, 2014
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·January 2, 2013
NRG KNEE P/S NRG BEARING INSERT S
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code JWH·November 3, 2010
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025